Document: leaflet MAH GENERIC_PL 16363-0463 change

• leaflet MAH GENERIC_PL 16363-0463
• leaflet MAH GENERIC_PL 30684-0222

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Package leaflet: Information for the user

Tramadol hydrochloride and Paracetamol 37.5mg/325mg film-coated tablets

Tramadol hydrochloride/Paracetamol

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Tramadol hydrochloride and Paracetamol is and what it is used for

2.    What you need to know before you take Tramadol hydrochloride and Paracetamol

3.    How to take Tramadol hydrochloride and Paracetamol

4.    Possible side effects

5.    How to store Tramadol hydrochloride and Paracetamol

6.    Contents of the pack and other information

1. What Tramadol hydrochloride and Paracetamol is and what it is used for

Tramadol hydrochloride and Paracetamol is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed.

2. What you need to know before you take Tramadol hydrochloride and Paracetamol

Do not take Tramadol hydrochloride and Paracetamol:

•    if you are hypersensitive or have had an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) to tramadol hydrochloride, paracetamol or any of the other ingredients of this medicine (listed in section 6)

•    in cases of acute alcohol poisoning

•    if you are taking sleeping pills, pain relievers or medicines that affect mood and emotions

•    if you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with Tramadol hydrochloride and Paracetamol. MAOIs are used in the treatment of depression or Parkinson's disease.

•    if you have a severe liver disorder

•    if you have epilepsy that is not adequately controlled by your current medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol hydrochloride and Paracetamol

•    take other medicines containing paracetamol or tramadol

•    have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice

•    have kidney problems

•    have severe difficulties in breathing, for example asthma or severe lung problems

•    have epilepsy or have already experienced fits or seizures

•    have recently suffered from a head injury, shock or severe headaches associated with vomiting (being sick)

•    are dependent on any medicine (for example morphine)

•    take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine

•    are going to have an anaesthetic (tell your doctor or dentist that you are taking Tramadol hydrochloride and Paracetamol).

Other medicines and Tramadol hydrochloride and Paracetamol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you which medicines are safe to take with Tramadol hydrochloride and Paracetamol.

Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.

Do not take Tramadol hydrochloride and Paracetamol with MAOIs (see section 'Do not take Tramadol hydrochloride and Paracetamol').

Tramadol hydrochloride and Paracetamol is not recommended with the following medicines, as it may affect how well they work:

•    carbamazepine (a medicine used to treat epilepsy or some types of pain)

•    buprenorphine, nalbuphine or pentazocine (opioidtype pain relievers).

Tramadol hydrochloride and Paracetamol may increase the risk of side effects if you also take the following medicines:

•    if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take Tramadol hydrochloride and Paracetamol at the same time. Your doctor will tell you whether Tramadol hydrochloride and Paracetamol is suitable for you.

•    If you are taking certain antidepressants. Tramadol hydrochloride and Paracetamol may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C.

•    tranquilizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), baclofen (a muscle relaxant), medicines used to lower blood pressure, antidepressants or medicines to treat allergies. Check with your doctor if you feel drowsy or feel faint.

•    anaesthetics, medicines that affect the state of mind, or bupropion (used to help stop smoking). The risk of having a fit may increase. Your doctor will tell you whether Tramadol hydrochloride and Paracetamol is suitable for you.

•    warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur (see section 4).

The effectiveness of Tramadol hydrochloride and Paracetamol may be altered if you also take the following medicines:

•    metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting/being sick)

•    cholestyramine (medicine used to reduce cholesterol in the blood)

•    ketoconazole or erythromycin (medicines used against infections).

Tramadol hydrochloride and Paracetamol with food and drink and alcohol

Do not drink alcohol while you are taking Tramadol hydrochloride and Paracetamol, as you may feel drowsy.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Tramadol hydrochloride and Paracetamol while you are pregnant.

Do not take Tramadol hydrochloride and Paracetamol while you are breastfeeding, as small amounts of tramadol may pass into the breast-milk.

Driving and using machines

If you feel drowsy while taking Tramadol hydrochloride and Paracetamol, do not drive, use tools or use machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine

3. How to take Tramadol hydrochloride and Paracetamol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole with sufficient liquid.

Do not break or chew the tablets.

Take Tramadol hydrochloride and Paracetamol for as short a time as possible and no longer than your doctor has told you.

The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.

Adults and adolescents over 12 years:

The recommended dosage is to start with 2 tablets, unless otherwise prescribed by your doctor. If required, further doses may be taken, as instructed by your doctor.

The shortest time between doses must be at least 6 hours.

Do not take more than 8 tablets in 24 hours.

Your doctor may increase the time between doses if:

•    you are older than 75 years

•    you have kidney problems

•    you have liver problems.

Children under 12 years of age:

•    not recommended.

Elderly patients

In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.

Severe liver or kidney disease (insufficiency)/ dialysis patients

Patients with severe liver and/or kidney insufficiency should not take Tramadol hydrochloride and Paracetamol. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

If you think that the effect of Tramadol hydrochloride and Paracetamol is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have enough pain relief), contact your doctor.

If you take more Tramadol hydrochloride and Paracetamol than you should

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you forget to take Tramadol hydrochloride and Paracetamol

If you forget to take the tablets, pain is likely to return.

Do not take a double dose to make up for forgotten individual doses; simply continue taking the tablets as usual.

If you stop taking Tramadol hydrochloride and Paracetamol

Generally, there will be no after-effects when treatment with Tramadol hydrochloride and Paracetamol is stopped.

Rarely, people who have been using a medicine containing tramadol may become dependent on it, making it hard to stop taking it. If you have been taking Tramadol hydrochloride and Paracetamol for some time and want to stop, contact your doctor because your body may have become used to Tramadol hydrochloride and Paracetamol.

People may:

•    feel agitated, anxious, nervous or shaky

•    be over active

•    have difficulty sleeping

•    have stomach or bowel disorders.

Very few people may also get:

•    panic attacks

•    hallucinations, unusual perceptions such as itching, tingling and numbness

•    ringing in the ears.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Other side effect information is listed in section 4.

4. Possible side effects

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

Some side effects could be serious. Contact your doctor immediately if any of the following occur:

•    rarely cases of skin rash, indicating an allergic reaction, may develop with sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting. If this happens to you, stop treatment. Do not take the medicine again.

•    prolonged or unexpected bleeding, from the use of Tramadol hydrochloride and Paracetamol with medicines used to thin the blood (e.g. warfarin, phenprocoumon).

Additionally, if any of the following side effects get serious, contact your doctor or pharmacist:

Very common side effects (affecting more than 1 in 10 people treated)

•    nausea

•    dizziness, drowsiness.

Common side effects (affecting less than 1 in 10, but more than 1 in 100 people treated)

•    vomiting (being sick), digestion problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth

•    itching, sweating

•    headache, shaking

•    confusion, sleep disorders, mood changes (anxiety, nervousness, feeling of extreme happiness).

Uncommon side effects (affecting less than 1 in 100, but more than 1 in 1,000 people treated)

•    increase in pulse or blood pressure, heart rate or heart rhythm disorders

•    difficulty or pain on passing water

•    skin reactions (for example rashes, hives)

•    tingling, numbness or feeling of pins and needles in the limbs, ringing in the ears, involuntary muscle twitching

•    depression, nightmares, hallucinations (hearing, seeing or sensing things that are not really there), memory lapses

•    difficulty swallowing, blood in the stools

•    shivering, hot flushes, pain in the chest

•    difficulty breathing.

Rare side effects (affecting less than 1 in 1,000, but more than 1 in 10,000 people treated)

•    fits, uncoordinated movements

•    addiction

•    blurred vision.

•    transient loss of consciousness (syncope).

Unknown: (cannot be estimated from the available data)

•    decrease in blood sugar level

In addition, the following side effects have been reported by people using medicines that contain only tramadol or only paracetamol:

•    feeling faint when getting up from a lying or sitting position, slow heart rate, fainting

•    changes in appetite

•    muscle weakness, slower or weaker breathing

•    mood changes, changes in activity, changes in perception

•    worsening of existing asthma

•    nose bleeds or bleeding gums, which may result from a low blood platelet count.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tramadol hydrochloride and Paracetamol

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label, carton, and blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tramadol hydrochloride and Paracetamol contains

-    The active substances are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.

-    The other ingredients are

Tablet core: Maize starch, powdered cellulose, sodium starch glycolate (Type A), starch, pregelatinized, Magnesium Stearate Film-coating: Hypromellose, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172), polysorbate 80

What Tramadol hydrochloride and Paracetamol looks like and contents of the pack

Film-coated tablets

Light yellow, oblong shaped biconvex film coated tablets debossed with “I 03” on one side and plain on the other side.

Tramadol hydrochloride and Paracetamol film-coated tablets are available in PVC/PVdC - Aluminium foil blister pack and HDPE container pack with polypropylene closure.

Pack sizes:

Blister pack: 10, 20, 30, 60 ,90 & 100 film-coated tablets HDPE pack: 30, 250 & 1000 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

or

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

This leaflet was last revised in 12/2015.