Tramadol hydrochloride + paracetamol brillpharma

PACKAGE LEAFLET: INFORMATION FOR THE

USER
Tramadol Hydrochloride + Paracetamol Bristol Laboratories, 37.5 mg + 325 mg,
film-coated tablets
Tramadol hydrochloride + Paracetamol
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist.
Contents of the leaflet:
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
Tramadol Hydrochloride + Paracetamol Bristol Laboratories, 37.5 mg + 325 mg, film-coated tablets is a combination medicine containing two analgesics — tramadol and paracetamol — which together help relieve pain.
This medicine is intended for the treatment of moderate to severe pain, when your doctor has determined that a combination of tramadol and paracetamol is necessary.
This medicine should only be used in adults and adolescents over 12 years of age.

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

When not to use Tramadol Hydrochloride + Paracetamol Bristol Laboratories

• If the patient has hypersensitivity to, or has experienced 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 the patient is simultaneously taking sedatives, painkillers, or medicines affecting mood and emotions.
• If the patient is currently taking monoamine oxidase inhibitors (MAOIs) or has taken them within 14 days prior to starting treatment with tramadol and paracetamol tablets. MAO inhibitors are used in the treatment of depression and Parkinson's disease.
• If the patient has severe liver disease.
• If the patient has epilepsy that is not adequately controlled by medication.

Warnings and precautions
Before starting to use this medicine, discuss it with your doctor or
pharmacist:

• If the patient is simultaneously taking other medicines containing paracetamol or tramadol.
• If the patient has liver dysfunction or liver disease, or if yellowing of the eyes or skin occurs, which may indicate jaundice.
• If the patient has impaired kidney function.
• If the patient has serious breathing problems, such as asthma or severe lung disease.
• If the patient has epilepsy or has previously experienced seizures.
• If the patient has recently suffered a head injury, concussion, or severe headaches accompanied by vomiting.
• If the patient is dependent on any drugs, including painkillers such as morphine.
• If the patient is taking other painkillers containing buprenorphine, nalbuphine, or pentazocine. If the patient is due to undergo anesthesia, inform the doctor or dentist about taking this medicine.

Tramadol Hydrochloride + Paracetamol Bristol Laboratories and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken by the
patient, including those available without a prescription. The doctor
will inform the patient which medicines can be safely used together with this medicine.
Do not exceed the maximum daily doses of paracetamol and tramadol when using this or other medicines. Tramadol Hydrochloride + Paracetamol Bristol Laboratories must not be used simultaneously with monoamine oxidase inhibitors (MAOIs)
(see section: "When not to use Tramadol Hydrochloride + Paracetamol Bristol Laboratories").
Concomitant use of Tramadol Hydrochloride + Paracetamol Bristol Laboratories with the following medicines is not recommended due to possible interactions:

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

The risk of adverse effects increases when taking the following
medicines simultaneously:

• medicines that may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases when Tramadol Hydrochloride + Paracetamol Bristol Laboratories is taken concomitantly. Your doctor will advise whether it is safe to use this medicine.
• certain antidepressants. Tramadol Hydrochloride + Paracetamol Bristol Laboratories may interact with these medicines, possibly causing symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, excessive sweating, tremor, increased reflexes, increased muscle tone, and elevated body temperature above 38°C.

If confusion, restlessness, fever, sweating, uncoordinated limb or eye movements, uncontrolled muscle spasms, or diarrhea occur, inform your doctor.

• sedatives, sleeping pills, other painkillers such as morphine and codeine (also in cough suppressants), baclofen (a muscle relaxant), blood pressure-lowering medicines, antidepressants, or medicines used to treat mood disorders. Drowsiness or weakness may occur. If these symptoms occur, inform your doctor.
• antidepressants, anesthetics, medicines affecting mental state, or bupropion (a medicine used to help quit smoking). The risk of seizures may increase. Your doctor will advise whether it is safe to use this medicine.
• warfarin or phenprocoumon (medicines that reduce blood clotting). The effect of these medicines may change, leading to bleeding (see section 4).

The effect of Tramadol Hydrochloride + Paracetamol Bristol Laboratories may be altered if the patient is also taking:

• metoclopramide, domperidone, or ondansetron (used to treat nausea and vomiting),
• cholestyramine (a medicine that lowers blood cholesterol levels),
• ketoconazole or erythromycin (medicines used to treat infections).

Taking Tramadol Hydrochloride + Paracetamol Bristol Laboratories with
food and drink
Do not consume alcohol while taking this medicine, as it may cause drowsiness.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Breastfeeding
Tramadol is excreted in breast milk. Therefore, Tramadol Hydrochloride + Paracetamol Bristol Laboratories should not be taken more than once during breastfeeding. Alternatively, if the patient takes Tramadol Hydrochloride + Paracetamol Bristol Laboratories more than once, breastfeeding should be discontinued.
Driving and using machines:
If the patient feels drowsy while taking this medicine, do not drive, use tools, or operate machinery.

3. How to use Tramadol Hydrochloride + Paracetamol Bristol Laboratories

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. Tablets should be swallowed whole with an adequate amount of liquid. Do not divide or chew the tablets.
Dosage should be adjusted according to the intensity of pain and individual sensitivity to pain. Generally, the lowest effective dose providing adequate pain relief should be used.
Adults and adolescents over 12 years of age:
If not otherwise directed by a physician, the usual initial dose is 2 tablets. Further doses may be taken as needed, 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 this medicine per day.
Elderly patients
In patients over 75 years of age, elimination of the medicine from the body may be slowed. In such cases, your doctor may recommend extending the interval between doses.
Patients with severe hepatic or renal impairment, dialysis patients
This medicine must not be used in patients with severe liver disease and/or renal failure. In cases of moderate or mild impairment, your doctor may recommend extending the interval between doses.
Use in children under 12 years of age:

• Use of this medicine is not recommended in children under 12 years of age. If the patient feels that the effect of the medicine is too strong (e.g. experiences increased drowsiness or has difficulty breathing) or too weak (i.e. pain persists), consult your doctor.

Taking more than the recommended dose of Tramadol Hydrochloride + Paracetamol Bristol Laboratories
Seek immediate medical advice from a doctor or pharmacist, even if the patient feels well. There is a risk of serious liver damage, which may manifest later.
If you miss a dose of Tramadol Hydrochloride + Paracetamol Bristol Laboratories
If a dose is missed, pain may return. Do not take a double dose to make up for the missed dose. Take the next tablet at the usual scheduled time.
Stopping treatment with Tramadol Hydrochloride + Paracetamol Bristol Laboratories
Usually, no withdrawal effects are experienced when stopping Tramadol Hydrochloride + Paracetamol Bristol Laboratories.
However, in rare cases, use of tramadol-type medicines may lead to dependence, which could make discontinuation difficult.
In rare cases, medicines containing tramadol may cause dependence, which may complicate stopping treatment. If Tramadol Hydrochloride + Paracetamol Bristol Laboratories has been used for a prolonged period, consult your doctor before stopping treatment, as dependence may have developed.
The following symptoms may occur:

• restlessness, anxiety, tremor
• excessive activity
• sleep disturbances
• gastrointestinal problems.

In a very small number of individuals, the following may also occur:

• panic attacks
• hallucinations, unusual sensations such as itching, tingling, and numbness
• tinnitus.

If any of these symptoms occur after stopping this medicine, consult your doctor. Information on other adverse effects is provided in section 4.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be very serious. If any of the following symptoms occur,
contact your doctor immediately:

• Rare skin rash indicating an allergic reaction, possibly accompanied by sudden swelling of the face and neck, difficulty breathing, or low blood pressure and fainting. If any of these conditions occur, discontinue this medicine immediately. Do not take it again.
• Prolonged or unexpected bleeding caused by concomitant use of Tramadol Hydrochloride + Paracetamol Bristol Laboratories with medicines that reduce blood clotting (e.g. phenprocoumon, warfarin).

Additionally, contact your doctor or pharmacist if any of the following adverse effects
become severe:

Very common adverse effects (may affect more than 1 in 10 patients)

• nausea
• dizziness, drowsiness

Common adverse effects (may affect up to 1 in 10 patients)

• vomiting, gastrointestinal disturbances (constipation, bloating, diarrhoea), abdominal pain, dry mouth,
• itching, increased sweating,
• headache, tremor,
• confusion, sleep disturbances, mood changes (anxiety, restlessness, euphoria).

Uncommon adverse effects (may affect more than 1 in 100 patients)

• increased heart rate or elevated blood pressure, disturbances in heart function or rhythm,
• difficulty or pain when passing urine,
• skin reactions (e.g. rashes, urticaria),
• tingling, numbness or pins and needles in limbs, tinnitus, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not there), temporary memory problems,
• difficulty swallowing, blood in stool,
• chills, hot flushes, chest pain,
• shortness of breath.

Rare adverse effects (may affect more than 1 in 1,000 patients)

• seizures, difficulty with coordination,
• dependence,
• blurred vision.

The following adverse effects have been reported by people using medicines containing only tramadol or only paracetamol.
If any of these symptoms occur while taking this medicine, inform your doctor:

• feeling faint when changing position from lying or sitting to standing, slowed heart rate, fainting, changes in appetite,
• muscle weakness, slower or shallower breathing,
• mood changes, changes in activity, perceptual disturbances,
• worsening of asthma. If any of these conditions occur, discontinue this medicine and contact your doctor immediately. Do not take this medicine again.

In rare cases, people who have used tramadol for a long time may sometimes feel unwell after abruptly stopping treatment. They may experience restlessness, anxiety, nervousness or tremor. They may become hyperactive, have difficulty sleeping, and experience gastric or gastrointestinal disturbances. In very rare cases, patients may experience panic attacks, hallucinations, unusual sensations such as itching, tingling and numbness, and tinnitus.
If any of these symptoms occur after discontinuation of this medicine, contact your doctor.

In exceptional cases, blood test results may be abnormal, for example indicating a low platelet count, which may cause nosebleeds or bleeding gums.
Use of this medicine together 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 adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

In rare cases, a skin rash indicating an allergic reaction may occur, together with sudden swelling of the face and neck, difficulty breathing, low blood pressure and fainting.

Reporting of adverse effects
If patients experience any adverse effects, including any possible adverse effects not listed in this leaflet, they should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder. e-mail:
[email protected]
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store the medicine Tramadol Hydrochloride + Paracetamol Bristol

Laboratories

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box and blister after: (EXP). The expiry date refers to the last day of the specified month.
• This medicine does not require any special storage conditions.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Tramadol Hydrochloride + Paracetamol Bristol Laboratories contains
The active substances in this medicine are tramadol hydrochloride and paracetamol.
One (1) coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
Other ingredients:

• Tablet core: microcrystalline cellulose, maize starch, sodium carboxymethyl starch (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, biconvex, coated tablet with the engraved text “C8” on one side.
Tramadol Hydrochloride + Paracetamol Bristol Laboratories, coated tablets, is packed in blisters made of PVC/aluminium foil, placed in a cardboard box.
Pack sizes contain 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
This medicinal product has marketing authorisation in the EEA Member States 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, Filmovertrukne tabletter