TRAMADOL 37.5 mg/325 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR
2. THE USER
3. Tramadol Hydrochloride + Paracetamol Bristol Laboratories, 37.5 mg + 325 mg,
   1. Tramadol Hydrochloride + Paracetamol
   2. You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient
   3. Contents of the pack:
4. What Tramadol Hydrochloride + Paracetamol Bristol Laboratories is and what it is used for
5. Important information before taking Tramadol Hydrochloride + Paracetamol Bristol Laboratories
   1. Tramadol Hydrochloride + Paracetamol Bristol Laboratories
   2. When not to take Tramadol Hydrochloride + Paracetamol Bristol Laboratories
   3. Warnings and precautions
   4. Before taking this medicine, you should discuss it with your doctor or pharmacist:
   5. Tramadol Hydrochloride + Paracetamol Bristol Laboratories with other medicines
   6. Taking Tramadol Hydrochloride + Paracetamol Bristol Laboratories with food and drink
   7. Pregnancy, breastfeeding and fertility
   8. Driving and using machines:
6. How to take Tramadol Hydrochloride + Paracetamol Bristol Laboratories
   1. Adults and adolescents over 12 years of age:
   2. Elderly patients
   3. Patients with severe liver or kidney impairment, patients on dialysis
   4. Use in children under 12 years of age:
   5. Taking a higher dose of Tramadol Hydrochloride + Paracetamol Bristol Laboratories than recommended
   6. Tramadol Hydrochloride + Paracetamol Bristol Laboratories
   7. Missing a dose of Tramadol Hydrochloride + Paracetamol Bristol Laboratories
   8. Tramadol Hydrochloride + Paracetamol Bristol Laboratories
   9. Stopping treatment with Tramadol Hydrochloride + Paracetamol Bristol Laboratories
   10. Tramadol Hydrochloride + Paracetamol Bristol Laboratories
7. Possible side effects
   1. Some side effects can be very serious. If you experience any of the following symptoms, you should immediately contact your doctor:
   2. You should also contact your doctor or pharmacist if you experience any of the following side effects:
   3. Very common side effects (may affect more than 1 in 10 people)
   4. Common side effects (may affect up to 1 in 10 people)
   5. Uncommon side effects (may affect up to 1 in 100 people)
   6. Rare side effects (may affect up to 1 in 1,000 people)
   7. Reporting side effects
8. How to store Tramadol Hydrochloride + Paracetamol Bristol Laboratories
   1. Tramadol Hydrochloride + Paracetamol Bristol Laboratories
9. Contents of the pack and other information
   1. What Tramadol Hydrochloride + Paracetamol Bristol Laboratories contains
   2. What Tramadol Hydrochloride + Paracetamol Bristol Laboratories looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Wave Pharma Limited
   7. Date of last revision of the leaflet:
   8. This medicinal product is authorized in the Member States of the EEA under the following names:

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR

THE USER

Tramadol Hydrochloride + Paracetamol Bristol Laboratories, 37.5 mg + 325 mg,

coated tablets

Tramadol Hydrochloride + Paracetamol

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient

You should keep this leaflet, so that you can read it again if you need to. 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 symptoms 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.

Contents of the pack:

What Tramadol Hydrochloride + Paracetamol Bristol Laboratories is and what it is used for Important information before taking Tramadol Hydrochloride + Paracetamol Bristol Laboratories How to take Tramadol Hydrochloride + Paracetamol Bristol Laboratories Possible side effects How to store Tramadol Hydrochloride + Paracetamol Bristol Laboratories Contents of the pack and other information

1. What Tramadol Hydrochloride + Paracetamol Bristol Laboratories is and what it is used for

what it is used for
Tramadol Hydrochloride + Paracetamol Bristol Laboratories, 37.5 mg + 325 mg, coated tablets is a combination medicine containing two painkillers - tramadol and paracetamol, which together relieve pain. This medicine is used to treat moderate or severe pain, when the doctor decides that a combination of tramadol and paracetamol is needed. This medicine should only be used in adults and adolescents over 12 years of age.

2. Important information before taking Tramadol Hydrochloride + Paracetamol Bristol Laboratories

Tramadol Hydrochloride + Paracetamol Bristol Laboratories

When not to take Tramadol Hydrochloride + Paracetamol Bristol Laboratories

• If you are hypersensitive to or have had allergic reactions (e.g. skin rash, facial swelling, wheezing or shortness of breath) to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6). In case of acute alcohol intoxication.
• If you are taking sleeping pills, painkillers or medicines that affect mood and emotions.
• If you are taking monoamine oxidase inhibitors (MAOIs) or have taken them within 14 days before starting treatment with tramadol and paracetamol tablets. MAOIs are used to treat depression and Parkinson's disease.
• If you have severe liver disease.
• If you have epilepsy that is not well controlled by the medicines you are taking.

Warnings and precautions

Before taking this medicine, you should discuss it with your doctor or pharmacist:

• If you are taking other medicines containing paracetamol or tramadol.
• If you have liver disorders or liver disease, or if you have jaundice (yellowing of the eyes or skin).
• If you have kidney problems.
• If you have severe breathing difficulties, such as asthma or severe lung disease.
• If you have epilepsy or have had seizures.
• If you have recently had a head injury, concussion, or severe headaches with vomiting.
• If you are addicted to any medicines, including painkillers such as morphine.
• If you are taking other painkillers containing buprenorphine, nalbuphine or pentazocine. If you are going to have an anaesthetic, you should tell your doctor or dentist that you are taking this medicine.

Tramadol Hydrochloride + Paracetamol Bristol Laboratories with other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those obtained without a prescription. Your doctor will inform you which medicines can be safely taken with this medicine. Do not exceed the maximum daily doses of paracetamol and tramadol when taking this or other medicines. Tramadol Hydrochloride + Paracetamol Bristol Laboratories should not be taken at the same time as monoamine oxidase inhibitors (MAOIs) (see section "When not to take Tramadol Hydrochloride + Paracetamol Bristol Laboratories").

• carbamazepine (a medicine used to treat epilepsy or certain types of pain),
• buprenorphine, nalbuphine or pentazocine (opioid painkillers).

The risk of side effects increases when taking the following medicines:

• medicines that can cause seizures, such as some antidepressants or antipsychotics. The risk of seizures increases when taking Tramadol Hydrochloride + Paracetamol Bristol Laboratories. Your doctor will tell you if you can safely take this medicine.
• certain antidepressants. Tramadol Hydrochloride + Paracetamol Bristol Laboratories may interact with these medicines, causing symptoms such as involuntary, rhythmic muscle contractions, including those controlling eye movements, excessive sweating, tremors, increased reflexes, increased muscle tone, and increased body temperature above 38°C.

If you experience confusion, restlessness, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrolled muscle contractions or diarrhea, you should inform your doctor.

• sedatives, sleeping pills, other painkillers such as morphine and codeine (also in the form of a cough medicine), baclofen (a muscle relaxant), blood pressure lowering medicines, antidepressants or medicines used to treat allergies. Drowsiness or weakness may occur. If you experience these symptoms, you should inform your doctor.
• antidepressants, anesthetics, medicines that affect the mind or bupropion (a medicine that helps quit smoking). The risk of seizures may increase. Your doctor will tell you if you can safely take this medicine.
• warfarin or phenprocoumon (medicines that reduce blood clotting). The effect of these medicines may change, and bleeding may occur (see section 4).

The effect of Tramadol Hydrochloride + Paracetamol Bristol Laboratories may change if you are also taking:

• metoclopramide, domperidone or ondansetron (used to treat nausea and vomiting),
• cholestyramine (a medicine that lowers cholesterol levels in the blood),
• ketokonazole or erythromycin (antibiotics).

Taking Tramadol Hydrochloride + Paracetamol Bristol Laboratories with food and drink

When taking this medicine, do not drink alcohol, as it may cause drowsiness.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Breastfeeding Tramadol is excreted into breast milk. For this reason, you should not take Tramadol Hydrochloride + Paracetamol Bristol Laboratories more than once during breastfeeding, or, if you take Tramadol Hydrochloride + Paracetamol Bristol Laboratories more than once, an alternative is to stop breastfeeding.

Driving and using machines:

If you feel drowsy when taking this medicine, do not drive, use tools or operate machinery.

3. How to take Tramadol Hydrochloride + Paracetamol Bristol Laboratories

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The tablets should be swallowed whole, with a sufficient amount of liquid. Do not divide or crush the tablets. The dose should be adjusted according to the intensity of the pain and individual sensitivity to pain. Usually, the lowest dose that relieves the pain should be taken.

Adults and adolescents over 12 years of age:

If your doctor has not prescribed otherwise, the usual initial dose is 2 tablets. If necessary, you can take further doses according to your doctor's instructions. The minimum interval between doses must be at least 6 hours. Do not take more than 8 tablets of the medicine per day.

Elderly patients

In patients over 75 years of age, the elimination of the medicine from the body may be slowed down. In such cases, your doctor may recommend prolonging the interval between doses.

Patients with severe liver or kidney impairment, patients on dialysis

Patients with severe liver disease and/or kidney impairment should not take this medicine. In case of moderate or mild impairment, your doctor may recommend prolonging the interval between doses.

Use in children under 12 years of age:

• The use of this medicine in children under 12 years of age is not recommended. If you think that the effect of this medicine is too strong (e.g. you feel increased drowsiness or have difficulty breathing) or too weak (i.e. you still feel pain), you should consult your doctor.

Taking a higher dose of Tramadol Hydrochloride + Paracetamol Bristol Laboratories than recommended

Tramadol Hydrochloride + Paracetamol Bristol Laboratories

You should immediately contact a doctor or pharmacist, even if you feel well. There is a risk of serious liver damage, which may become apparent later.

Missing a dose of Tramadol Hydrochloride + Paracetamol Bristol Laboratories

Tramadol Hydrochloride + Paracetamol Bristol Laboratories

If you miss a dose, it is likely that the pain will return. Do not take a double dose to make up for the missed dose, but take the next tablet at the usual time.

Stopping treatment with Tramadol Hydrochloride + Paracetamol Bristol Laboratories

Tramadol Hydrochloride + Paracetamol Bristol Laboratories

Usually, you will not experience any withdrawal effects when stopping Tramadol Hydrochloride + Paracetamol Bristol Laboratories. In rare cases, taking a medicine like tramadol can lead to dependence, which can make it difficult to stop taking the medicine. In rare cases, taking a medicine containing tramadol can lead to dependence, which can make it difficult to stop taking the medicine. If you have been taking Tramadol Hydrochloride + Paracetamol Bristol Laboratories for a long time, before stopping treatment, you should consult your doctor, as you may have become dependent on the medicine. You may experience:

• restlessness, anxiety, feeling of fear or shakiness
• increased activity
• sleep problems
• stomach and intestinal problems.

In very rare cases, you may also experience:

• panic attacks
• hallucinations, unusual sensations such as itching, tingling and numbness
• ringing in the ears.

If you experience any of these symptoms after stopping this medicine, you should consult your doctor. Information about other side effects 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 can be very serious. If you experience any of the following symptoms, you should immediately contact your doctor:

• rare skin rash indicating an allergic reaction, which may be accompanied by sudden swelling of the face and neck, difficulty breathing or low blood pressure and fainting. If you experience these conditions, you should stop taking this medicine. Do not take it again.
• prolonged or unexpected bleeding caused by taking Tramadol Hydrochloride + Paracetamol Bristol Laboratories with medicines that reduce blood clotting (e.g. phenprocoumon, warfarin).

You should also contact your doctor or pharmacist if you experience any of the following side effects:

Very common side effects (may affect more than 1 in 10 people)

• nausea
• dizziness, drowsiness

Common side effects (may affect up to 1 in 10 people)

• vomiting, digestive disorders (constipation, bloating, diarrhea), abdominal pain, dry mouth,
• itching, increased sweating,
• headache, tremors,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria).

Uncommon side effects (may affect up to 1 in 100 people)

• rapid heartbeat or high blood pressure, heart rhythm disorders,
• difficult or painful urination,
• skin changes (e.g. rashes, hives),
• tingling, numbness or prickling sensation in the limbs, ringing in the ears, involuntary muscle contractions,
• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not there), temporary memory problems,
• difficulty swallowing, blood in the stool,
• chills, hot flushes, chest pain,
• shortness of breath.

Rare side effects (may affect up to 1 in 1,000 people)

• seizures, difficulty coordinating movements,
• addiction,
• blurred vision.

The following side effects have been reported by people taking medicines containing only tramadol or only paracetamol. If you experience any of these symptoms while taking this medicine, you should tell your doctor:

• feeling of fainting when changing position from lying or sitting to standing, slow heartbeat, fainting, changes in appetite,
• muscle weakness, slower or shallower breathing,
• mood changes, changes in activity, changes in perception,
• worsening of asthma. If you experience these conditions, you should stop taking this medicine and immediately contact your doctor. Do not take it again.

In rare cases, people who have been taking tramadol for a long time may feel unwell after suddenly stopping treatment. They may feel restless, anxious, nervous or shaky. They may be overactive, have difficulty sleeping and experience stomach or intestinal disorders. In very rare cases, they may experience panic attacks, hallucinations, unusual sensations such as itching, tingling and numbness, and ringing in the ears. If you experience any of these symptoms after stopping this medicine, you should contact your doctor. In exceptional cases, blood test results may be abnormal, e.g. indicating a low platelet count, which can cause nosebleeds or bleeding gums. Taking this medicine with anticoagulant medicines (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Prolonged or unexpected bleeding should be reported to your doctor immediately. If any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist. In rare cases, a skin rash indicating an allergic reaction may occur, accompanied by sudden swelling of the face and neck, difficulty breathing or low blood pressure and fainting.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. 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 the "Contact" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tramadol Hydrochloride + Paracetamol Bristol Laboratories

Tramadol Hydrochloride + Paracetamol Bristol Laboratories

• The medicine should be stored out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack after (EXP). The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tramadol Hydrochloride + Paracetamol Bristol Laboratories contains

The active substances of the medicine are tramadol hydrochloride and paracetamol. One (1) coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol. The other ingredients are:

• Tablet core:cellulose, powder, maize starch, sodium carboxymethylcellulose (type A), maize starch, magnesium stearate.
• Coating:hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide yellow (E 172), polysorbate 80.

What Tramadol Hydrochloride + Paracetamol Bristol Laboratories looks like and contents of the pack

Tramadol Hydrochloride + Paracetamol Bristol Laboratories is a light yellow, oblong, biconvex, coated tablet with "C8" engraved on one side. Tramadol Hydrochloride + Paracetamol Bristol Laboratories, coated tablets are packaged in PVC/Aluminum blisters in a cardboard box. The packs contain 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin Ireland

Manufacturer

Wave Pharma Limited

4th Floor Cavendish House, 369 Burnt Oak Broadway, Edgware, HA8 5AW United Kingdom

Date of last revision of the leaflet:

This medicinal product is authorized in the Member States of the EEA under the following names:

PT — Tramadol + Paracetamol Bristol Laboratories, 37.5 mg + 325 mg, Comprimido revestido por pelicula
ES — Tramadol/Paracetamol Bristol Laboratories 37,5 mg/325 mg comprimidos recubiertos con película
DK — Tramadolhydrochlorid/ Paracetamol Bristol Laboratories, 37,5 mg / 325 mg, Filmovertrunkne tabletter