Scheriproct Ointment

INTENDIS

Scheriproct
Ointment

(1.9 mg prednisolone hexanoate / 5.0 mg cinchocaine hydrochloride per 1 g)

Scheriproct
Suppositories

(1.3 mg prednisolone hexanoate / 1.0 mg cinchocaine hydrochloride per suppository)

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If you experience any side effect and this becomes serious, tell your doctor or pharmacist.

In this leaflet:

• 
  1. What Scheriproct is and what it is used for
  


• 
  2. Before you use Scheriproct
  


• 
  3. How to use Scheriproct
  


• 
  4. Possible side effects
  


• 
  5. How to store Scheriproct
  


• 
  6. Further information
  

What Scheriproct is and what it is used for

Scheriproct contains a substance which reduces inflammation (predinisolone) and a local anaesthetic (cinchocaine) which relieves pain.

This medicine is used for the relief of the inflammation, swelling, itching and soreness of piles (haemorrhoids) and to relieve itching of the anus (back passage). It is used short-term usually for 5 to 7 days.

Before you use Scheriproct

Do not use Scheriproct if you:

• are allergic (hypersensitive) to prednisolone hexanoate, cinchocaine hydrochloride, other local anaesthetics or any of the other ingredients of Scheriproct.


• have a viral infection (e.g. herpes, shingles, chicken-pox)


• have any bacterial or fungal infections of the skin or elsewhere for which you are not receiving treatment.

Take special care with Scheriproct

• Long-term continuous treatment should be avoided because it increases the possibility of side effects. This is particularly important for infants and small children because continuous treatment with Scheriproct for long periods
  may reduce the activity of the adrenal glands and so lower resistance to disease. Also, long-term treatment can cause the skin to thin and deteriorate in the affected area (see section 4, “Possible Side Effects”) and some of the medicine may be absorbed into the blood stream.


• If the area treated with Scheriproct is also infected your doctor should prescribe another medicine, to use with Scheriproct, to treat the infection.


• Do not use a waterproof dressing to cover areas where you have applied the cream.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Contact your doctor for advice before using this medicine if you are pregnant or intending to become pregnant or are breast-feeding. There may be a very small risk to the development of a baby in pregnant women treated with Scheriproct. As with most medicines, this risk is likely to be greatest during the first 3 months of pregnancy.

Driving and using machines

Scheriproct has no influence on the ability to drive and use machines.

How to use Scheriproct

Always use Scheriproct exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not use Scheriproct for more than 7 days.

Always wash your hands before and after applying Scheriproct.

How to use Scheriproct Ointment:

• 1. Before you use the ointment, gently but thoroughly wash and dry the anus (back passage) and the skin around it.


• 2. If the ointment is to be used for the area around the anus:
  

• Squeeze a small quantity (about the size of a pea) on to the top of your finger.


• Spread it gently over the skin and just inside the anus.


• Do not rub it in.

• 3. If the ointment is to be used inside the anus:

• Put the separate nozzle (applicator) onto the tube.


• Squeeze the tube until the nozzle is full of ointment. The amount of ointment in the nozzle is one dose.


• Insert the nozzle very carefully into the anus until the whole length of the nozzle is inside.


• Then, while squeezing the tube gently, withdraw the nozzle.


• Wash the nozzle carefully in hot soapy water and rinse thoroughly.

Generally, the ointment should be applied twice a day, but it may be applied three or four times on the first day, to obtain quick relief.

How to use Scheriproct Suppositories:

• 1. Before you insert a suppository find the small tear in the foil packet and remove the covering foil, by tearing it in half.


• 2. If the suppositories have become softened, owing to warm temperature, they can be hardened by putting them into cold water before you remove the covering foil.


• 3. Insert the whole suppository into the anus.


• 4. To make insertion easier, either stand with one foot raised on a chair or squat down.

The usual treatment is one suppository a day, to be inserted preferably after a bowel movement. However, if your discomfort is severe, you should insert one suppository two or three times a day at the start of treatment.

If you use more Scheriproct than you should or if you accidentally swallow some Scheriproct

If you use too much Scheriproct or accidentally swallow Scheriproct it is unlikely to be dangerous but contact your doctor or pharmacist if you are worried.

If you forget to use Scheriproct

Do not use a double dose to make up for a forgotten dose. When you remember, use the next prescribed dose and continue with the treatment. See your doctor or pharmacist, if you are worried.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Scheriproct Ointment Side Effects

Like all medicines, Scheriproct can cause side effects, although not everybody gets them.

Some thinning of the skin may occur if too much Scheriproct is applied for long periods of time (much longer than 5 to 7 days).

Allergic skin reactions may occur in rare cases. Castor oil, one of the ingredients of Scheriproct Ointment may cause a skin reaction.

If you experience any of these side effects and this becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Scheriproct

• 
  Store Scheriproct out of the reach and sight of children.
  


• There are no special storage precautions for Scheriproct Ointment.


• Do not store Scheriproct Suppositories above 25ºC.


• Do not use Scheriproct after the expiry date which is stated on the pack.


• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Scheriproct Ointment contains

• The active substances are prednisolone hexanoate and cinchocaine hydrochloride. 1 g of Scheriproct Ointment contains 1.9 mg prednisolone hexanoate and 5.0 mg cinchocaine hydrochloride


• The other ingredients are polyethylene glycol 400 monoricinoleate, hydrogenated castor oil, castor oil, 2 octyldodecanol, chypre perfume oil.

What Scheriproct Suppositories contain

• The active substances are prednisolone hexanoate and cinchocaine hydrochloride. Each suppository contains 1.3 mg prednisolone hexanoate and 1.0 mg cinchocaine hydrochloride


• The other ingredient is hard fat.

What Scheriproct looks like and contents of the pack

• 
  Scheriproct Ointment is a colourless to slightly yellowish ointment supplied in tubes of 30g.


• 
  Scheriproct Suppositories are yellowish-white and are supplied in packs of 12 suppositories.

Marketing Authorisation Holder

Intendis GmbH

Max-Dohrn-Strasse 10

D-10589

Berlin

Germany

Manufacturer

The ointment is manufactured by:

Intendis Manufacturing, S.p.A

Milan

Italy

The suppositories are manufactured by:

Istituto de Angeli S.r.l.

Reggello

Italy

or

Intendis Manufacturing, S.p.A

Milan

Italy

Distributor in the UK

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop Stortford

CM22 6PU

UK

This leaflet was last approved in July 2009

Scheriproct is a registered trademark of Intendis GmbH.

81920967

Tensolisin

Tensolisin may be available in the countries listed below.

Ingredient matches for Tensolisin

Lisinopril

Lisinopril is reported as an ingredient of Tensolisin in the following countries:

• Dominican Republic


• Honduras

International Drug Name Search

Terbinafina Richet

Terbinafina Richet may be available in the countries listed below.

Ingredient matches for Terbinafina Richet

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafina Richet in the following countries:

• Argentina

International Drug Name Search

Typhim Vi

Pronunciation: TIE-foyd PAHL-ee-SACK-ah-ride
Generic Name: Typhoid Vi Polysaccharide Vaccine
Brand Name: Typhim Vi

Typhim Vi is used for:

Preventing typhoid fever in persons 2 years of age and older who are at increased risk because they are traveling to an area where this infection is more common, have been in contact with infected individuals, or work in an environment that increases their risk (eg, lab work).

Typhim Vi is a vaccine. It works by stimulating the immune system of the person who receives the vaccine to make their own protective antibodies against this disease.

Do NOT use Typhim Vi if:

• you are allergic to any ingredient in Typhim Vi


• you are already infected or are a carrier of typhoid

Contact your doctor or health care provider right away if any of these apply to you.

Before using Typhim Vi:

Some medical conditions may interact with Typhim Vi. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a weakened immune system or are unable to make antibodies due to HIV infection, cancer, or cancer therapy (eg, chemo or radiation) or you are taking medicines that suppress the immune system (eg, certain cancer medicines, corticosteroids such as methylprednisolone, cyclosporine)

Some MEDICINES MAY INTERACT with Typhim Vi. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Immunosuppressives (eg, certain cancer medicines, corticosteroids such as methylprednisolone, cyclosporine) because the effectiveness of Typhim Vi may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Typhim Vi may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Typhim Vi:

Use Typhim Vi as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Typhim Vi is administered as an injection at your doctor's office, hospital, or clinic.


• This vaccine should be given at least 2 weeks before being exposed to typhoid fever.


• If Typhim Vi contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Typhim Vi, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Typhim Vi.

Important safety information:

• Typhim Vi should be given 2 weeks prior to expected exposure.


• Side effects usually occur within 48 hours after receiving this vaccine. Contact your health care provider if any of the following symptoms persist for more than 2 days: tenderness, redness, pain, or hardening at the injection site; general body discomfort; headache; muscle pain; nausea; diarrhea; fever.


• Travelers should continue to take other precautions to avoid contact with possibly infected food or water.


• It is recommended that you receive another single dose of Typhim Vi every 2 years if you continue to be exposed to typhoid fever.


• Typhim Vi is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Typhim Vi during pregnancy. It is unknown if Typhim Vi is excreted in breast milk. If you are or will be breast-feeding while you are using Typhim Vi, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Typhim Vi:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; fever; general body discomfort; headache; muscle pain; nausea; tenderness, pain, redness, swelling, and hardening at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty swallowing; giant hives; hoarseness; shock.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Typhim Vi side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Typhim Vi:

Typhim Vi is usually handled and stored by a health care provider. If you are using Typhim Vi at home, store Typhim Vi as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Typhim Vi, please talk with your doctor, pharmacist, or other health care provider.


• Typhim Vi is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Typhim Vi. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Typhim Vi resources

• Typhim Vi Side Effects (in more detail)
• Typhim Vi Use in Pregnancy & Breastfeeding
• Typhim Vi Drug Interactions
• Typhim Vi Support Group
• 0 Reviews for Typhim Vi - Add your own review/rating

• Typhim Vi Advanced Consumer (Micromedex) - Includes Dosage Information


• typhoid vaccine, inactivated Subcutaneous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information


• Typhim VI Concise Consumer Information (Cerner Multum)


• Typhoid Vaccine Monograph (AHFS DI)

Compare Typhim Vi with other medications

• Typhoid Prophylaxis

Terbonile

Terbonile may be available in the countries listed below.

Ingredient matches for Terbonile

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbonile in the following countries:

• Turkey

International Drug Name Search

Six Plus Parapaed Paracetamol Suspension 250mg / 5ml

1. Name Of The Medicinal Product

Six Plus Parapaed Paracetamol Suspension 250mg/5ml

Paracetamol Suspension 250mg/5ml

Six Plus Paracetamol Suspension 250mg/5ml

Asda 6+ Paracetamol Oral Suspension 250mg/5ml

Enterprise Six Plus Paracetamol Suspension 250mg/5ml

Lexon 6+ Paracetamol Oral Suspension 250mg/5ml

Paracetamol 250mg/5ml Oral Suspension

2. Qualitative And Quantitative Composition

Each 5ml spoonful contains Paracetamol BP 250mg

3. Pharmaceutical Form

Oral Suspension.

Orange to orange/brown suspension with orange odour and taste.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of mild to moderate pain and as an anti-pyretic. Used for the relief of pain and feverishness associated with teething, toothache, headache, colds and flu.

4.2 Posology And Method Of Administration

Child's Age	How Much	How often (in 24 hours)
6 – 8 years	One 5 ml spoonful (large end)	4 times
8 – 10 years	One 5.0 ml spoonful (large end) and one 2.5 ml spoonful (small end)	4 times
10 – 12 years	Two 5 ml spoonfuls (large end)	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist • Do not give to children under the age of 6 years

Children aged 12 - 16 years: Two – three 5 ml spoonfuls (large end) up to 4 times a day.

Adults and children over 16 years: Two – four 5 ml spoonfuls (large end) up to 4 times a day.

It is important to shake the bottle for at least 10 seconds before use.

4.3 Contraindications

Hypersensitivity to Paracetamol or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of Paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease.

The label should contain the following statements:

• Contains paracetamol.

• Do not give this medicine with any other paracetamol-containing product.

• For oral use only.

• Never give more medicine than shown in the table.

• Do not overfill the spoon.

• Always use the spoon supplied with the pack.

• Do not give more than 4 doses in any 24 hour period.

• Leave at least 4 hours between doses.

• Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.

• As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.

• Do not store above 25°C. Store in the original package.

• Keep all medicines out of the reach and sight of children.

• Immediate medical advice should be sought in the event of an overdose, even if the child seems well (label).

• Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage (leaflet).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anti-coagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of Paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Drugs which induce hepatic microsomal enzymes such as alcohol. Concomitant barbiturates and tricyclic antidepressants may increase the hepatoxicity of Paracetamol particularly after overdose. Anti-convulsant or oral steroid contraceptives have the ability to reduce serum levels of Paracetamol by liver enzyme induction.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data does not contraindicate breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to Paracetamol. With prolonged use or overdosage, hepatic necrosis, acute pancreatitis and nephrotoxicity have been reported.

4.9 Overdose

Liver damage is possible in adults who have taken 10 g or more of Paracetamol. Ingestion of 5 g or more of Paracetamol may lead to liver damage if the patient has risk factors.

Risk Factors

If the patient:

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes.

or

b, Regularly consumes ethanol in excess of recommended amounts.

or

c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within one 1 hour. Plasma Paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependent on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the half life in plasma is 1 to 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 50% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 to 100% of the drug may be recovered in the urine within the first day. However, practically no Paracetamol is excreted unchanged, and the bulk is excreted after hepatic conjugation.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethanol (96%)

Sorbitan Monooleate

Glycerol (E422)

Magnesium Aluminium Silicate

Hydrogenated Glucose Syrup (E965)

Saccharin Sodium (E954)

Xanthan Gum

Sunset Yellow (E110)

Orange Flavour 6902

Sodium Benzoate (E211)

Citric Acid (monohydrate)

Polysorbate 80

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Amber glass bottles – 3 years

High density polyethylene – 3 years.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original container.

6.5 Nature And Contents Of Container

Pharmaceutical grade III amber glass bottles with pilfer proof screw caps.

Pack sizes: 70ml, 100ml, 150ml, 200ml, 500ml, 1 Litre and 2 Litre.

High density polyethylene bottles with tamper evident plastic cap.

Pack sizes: 500ml, 1 Litre and 2 Litre.

6.6 Special Precautions For Disposal And Other Handling

As for all medicines – no special requirements.

7. Marketing Authorisation Holder

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co. Tipperary

Ireland

8. Marketing Authorisation Number(S)

PL 04917/0010

9. Date Of First Authorisation/Renewal Of The Authorisation

23/03/2007

10. Date Of Revision Of The Text

07/10/2011

Nucynta ER

Generic Name: tapentadol (ta PEN ta dol)

Brand Names: Nucynta, Nucynta ER

What is Nucynta ER (tapentadol)?

Tapentadol is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Tapentadol is used to treat moderate to severe chronic pain.

Tapentadol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Nucynta ER (tapentadol)?

You should not use this medication if you are allergic to tapentadol, or if you have severe liver or kidney disease, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus. Do not use tapentadol if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Tapentadol may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking tapentadol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take tapentadol in larger amounts, or for longer than recommended by your doctor. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop using tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using tapentadol.

What should I discuss with my healthcare provider before taking Nucynta ER (tapentadol)?

You should not use this medication if you are allergic to tapentadol, or if you have severe liver or kidney disease, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus. Do not use tapentadol if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

To make sure you can safely take tapentadol, tell your doctor if you have any of these other conditions:

• 
  

  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• liver or kidney disease;


• 
  

  curvature of the spine;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  gallbladder disease or pancreas problems;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Tapentadol may cause breathing problems and addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Tapentadol can pass into breast milk and may harm a nursing baby. Do not breast-feed while taking this medication.

Older adults may be more sensitive to the effects of this medicine.

Tapentadol may be habit forming and should be used only by the person it was prescribed for. Never share tapentadol with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Do not give tapentadol to a child.

How should I take Nucynta ER (tapentadol)?

Take exactly as prescribed. Never take tapentadol in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Your doctor may occasionally change the timing of your dose to make sure you get the best results.

Take this medicine with a full glass of water.

You may take tapentadol with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Tapentadol can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.

Do not stop using tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using tapentadol. Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Tapentadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Ask a pharmacist about how to dispose of any unused pills after you have stopped taking tapentadol.

Never crush a tablet or other pill to mix into a liquid for snorting tapentadol or injecting the drug into your vein. This practice has resulted in death with the misuse of narcotic pain medicines and similar prescription drugs.

What happens if I miss a dose?

Since tapentadol is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of tapentadol can be fatal.

Overdose symptoms may include extreme drowsiness, blurred vision, confusion, vomiting, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking Nucynta ER (tapentadol)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not drink alcohol while you are using tapentadol. Dangerous side effects or death can occur when alcohol is combined with tapentadol. Check your food and medicine labels to be sure these products do not contain alcohol.

Nucynta ER (tapentadol) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  weak or shallow breathing, weak pulse, slow heartbeat;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  severe drowsiness or dizziness;

  
  


• 
  

  confusion, problems with speech or balance; or

  
  


• 
  

  agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting;

  
  


• 
  

  constipation;

  
  


• 
  

  mild dizziness, drowsiness;

  
  


• 
  

  dry mouth;

  
  


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  itching; or

  
  


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  increased sweating.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Nucynta ER (tapentadol)?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by tapentadol. Tell your doctor if you regularly use any of these medicines, or any other narcotic pain medicines.

There may be other drugs that can interact with tapentadol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Nucynta ER resources

• Nucynta ER Side Effects (in more detail)
• Nucynta ER Use in Pregnancy & Breastfeeding
• Nucynta ER Drug Interactions
• 3 Reviews for Nucynta ER - Add your own review/rating

• Nucynta ER Prescribing Information (FDA)


• Nucynta ER Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Nucynta ER Advanced Consumer (Micromedex) - Includes Dosage Information


• Tapentadol Professional Patient Advice (Wolters Kluwer)


• Nucynta MedFacts Consumer Leaflet (Wolters Kluwer)


• Nucynta Prescribing Information (FDA)


• Nucynta Consumer Overview


• Nucynta Monograph (AHFS DI)

Compare Nucynta ER with other medications

• Pain

Where can I get more information?

• Your pharmacist can provide more information about tapentadol.

See also: Nucynta ER side effects (in more detail)