Patient Information Leaflet

Tensyopar, 380 mg + 300 mg, tablets
Methocarbamolum + Paracetamolum
Please read all of 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 consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

What Tensyopar is and what it is used for
Important information before taking Tensyopar
How to take Tensyopar
Possible side effects
How to store Tensyopar
Contents of the pack and other information

1. What Tensyopar is and what it is used for

This medicinal product is a combination of an analgesic and antipyretic (pain-relieving and fever-reducing agent) and a muscle relaxant.
This medicinal product relieves muscle pain and stiffness and treats painful muscle spasms.
Treatment with methocarbamol should be as short as possible. Once pain subsides, your doctor will discontinue this medicine. The duration of treatment depends on symptoms but should not exceed 30 days.

2. Important information before taking Tensyopar

When not to take Tensyopar:

if the patient is allergic to methocarbamol, paracetamol, or any of the other ingredients of this medicine (listed in section 6),
if the patient has any brain disease,
if the patient has previously suffered brain damage or been in a coma,
if the patient has epilepsy or experiences seizures,
if the patient has muscle weakness (or a condition called myasthenia gravis).

Warnings and precautions
Do not take higher doses than recommended (see section 3. How to take Tensyopar).
The patient should ensure they are not simultaneously taking other medicines containing paracetamol
(e.g. cold and flu remedies or other antipyretic medicines).
Before starting Tensyopar, discuss this with your doctor or pharmacist:

if the patient regularly consumes alcohol (more than three alcoholic drinks per day);
if the patient suffers from chronic alcoholism, they should exercise caution and not take more than 2 g of paracetamol per day (maximum 6 tablets per day);
if the patient has any liver or kidney disease, the doctor may need to adjust the dose, extend the interval between doses, and emphasize the importance of not prolonging treatment beyond the necessary duration;
if the patient has heart or lung disease or anaemia;
if the patient has asthma with aspirin sensitivity;
if the patient is being treated with antiepileptic medicines. See below: Tensyopar with other medicines. Concurrent use reduces effectiveness and increases hepatotoxicity of paracetamol, especially when high doses of paracetamol are used.

During treatment, immediately inform the doctor if the patient develops severe conditions, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (an abnormality in blood and fluids) have been reported in patients who take paracetamol regularly for prolonged periods or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Effect on test results
If the patient is to undergo any diagnostic tests, they should inform the doctor that they are taking this medicine, as it may alter test results.
Paracetamol may affect analytical measurements of uric acid and glucose levels.
Tensyopar with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Methocarbamol may interact with the following medicines:

barbiturates (used in epilepsy treatment or to aid sleep),
appetite suppressants (used to assist weight loss),
anticholinergic medicines (used to treat cramps or painful intestinal and urinary bladder spasms or locomotor disease),
psychotropic medicines (used to treat anxiety, depression, or other mental disorders),
anaesthetics (if the patient is to undergo anaesthesia for any reason, they should inform the doctor or dentist that they are taking this medicine),
anticholinesterase agents (used in the treatment of myasthenia gravis).

Paracetamol may interact with the following medicines:

oral anticoagulants (used in the treatment of thromboembolic disorders),
antiepileptic medicines (used to treat seizures),
antibiotics (chloramphenicol),
hormonal contraceptives,
diuretics (used to increase urine excretion),
isoniazid (used in the treatment of tuberculosis),
metoclopramide and domperidone (used to treat nausea and vomiting),
probenecid (used in the treatment of gout),
propranolol (used to treat hypertension and cardiac disorders),
rifampicin (used in the treatment of tuberculosis),
anticholinergic medicines (used to treat cramps or painful intestinal and urinary bladder spasms),
zidovudine (used in the treatment of HIV infection),
cholestyramine (used to reduce blood cholesterol levels).

Inform the doctor or pharmacist if the patient is taking:

flucloxacillin (an antibiotic) due to a serious blood and fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2).

Do not take this medicine with other analgesics (painkillers) without consulting a doctor.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".
Taking Tensyopar with food, drink, and alcohol
Alcohol should be avoided while taking this medicine. Alcohol may intensify the central nervous system depressant effect of methocarbamol. Taking paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, liqueur, etc.) may cause liver damage.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor.
Pregnancy
Use of this medicine during pregnancy is not recommended. If a patient discovers she is pregnant during treatment, she should immediately consult her doctor, who will adjust the treatment accordingly.
Breastfeeding
Women who are breastfeeding should consult their doctor before taking this medicine. The doctor will discuss with the patient whether she should breastfeed her child. Methocarbamol and/or its metabolites have been detected in dog milk, but it is not known whether methocarbamol or its metabolites pass into human milk. Paracetamol passes into human milk, but not in clinically significant amounts.
Driving and operating machinery
The patient may experience drowsiness while taking this medicine; therefore, driving or operating machinery should be avoided until the patient's response to the medicine is known. This is particularly important if the patient has consumed alcohol or is taking other medicines that may also cause drowsiness.

3. How to take Tensyopar

This medicine should always be taken as directed by the doctor. In case of doubt, consult your
doctor.
Recommended dose:
Adults:
The recommended dose is 2 tablets, four to six times daily, depending on the severity of symptoms.
Do not take more than 12 tablets in 24 hours, and the interval between doses should not be less than
4 hours.
Elderly patients
Elderly patients may require a lower dose to achieve the same relief from pain and muscle spasms. The recommended dose is 1 tablet four times daily.
Patients with kidney/liver problems
May require longer intervals between doses.
Strictly follow the recommendations provided by the doctor (see section 2. Important information before taking Tensyopar).
Depending on the severity of kidney dysfunction, the doctor will inform the patient whether they should take 1 tablet every 6–8 hours.
If the patient has severe liver disease, they should not take more than 6 tablets within 24 hours.
Use in children and adolescents
Use in children or adolescents under 18 years of age is not recommended due to lack of data on safety and efficacy in this population.
This medicine is taken orally.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.
Tablets should be swallowed whole, without chewing, with an adequate amount of water.
Treatment with this medicine should be as short as possible. The doctor will determine the duration of treatment, which will depend on the occurrence of painful symptoms or muscle spasms. After symptoms subside, the doctor will discontinue the use of the medicine.
Remember to take the medicine as prescribed. Do not exceed the recommended dose.
If you feel that the effect of Tensyopar is too strong or too weak, contact your doctor or pharmacist.
Taking more than the recommended dose of Tensyopar
If you take more than the recommended dose of Tensyopar, contact your doctor, pharmacist, or hospital emergency department immediately. Bring the Tensyopar packaging with you.
Missing a dose of Tensyopar
Do not take a double dose to make up for a missed dose. If you are sure you forgot to take a tablet at the scheduled time, take it as soon as possible, then return to your regular dosing schedule. Always wait 4 hours before taking the next tablet. In case of doubt, contact your doctor or hospital.
Stopping Tensyopar
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
If any of the reactions listed below occur, stop treatment immediately and
inform your doctor without delay.

Allergic reactions ranging from simple skin rash or urticaria to more severe reactions such as anaphylactic reaction or angioedema (rash, itching, swelling of limbs, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing) or severe skin reactions;
Jaundice (yellowing of the skin and whites of the eyes), indicating liver disorders;
In case of infection with symptoms such as fever and pain, contact your doctor immediately, as this may indicate changes in white blood cells or platelets, reducing resistance to infections;
Seizures or fainting.

The following adverse effects may occur rarely (may affect no more than 1 in
1,000 people):

Headache, dizziness or feeling faint;
Conjunctivitis with nasal congestion;
Drop in blood pressure, metallic taste in the mouth, increased liver aminotransferase activity;
Fever, malaise.

The following adverse effects may occur very rarely (may affect no more
than 1 in 10,000 people):

Nausea, vomiting;
Nervousness, anxiety, disorientation, tremor, drowsiness, blurred vision, nystagmus (rapid and involuntary eye movements);
Low blood sugar concentration, decreased heart rate, skin redness (hot flushes);
Toxic effect on kidneys (dark discoloration of urine);
Shortness of breath.

The following adverse effects have been reported but their frequency cannot be determined from
available data (frequency unknown):

Mild disturbances in muscle coordination, memory loss, dizziness, insomnia, double vision;
Heartburn, dry mouth, fatigue, diarrhoea;
Serious condition causing blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the
safety of the medicine.

5. How to store Tensyopar

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required. Store in the original
packaging.
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 Tensyopar contains

The active substances in this medicine are methocarbamol and paracetamol. Each tablet contains 380 mg of methocarbamol and 300 mg of paracetamol.
Other ingredients are: stearic acid, pregelatinized corn starch, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica, povidone K-30, glycerol distearate (type I), sodium carboxymethyl starch (type A) and talc.

What Tensyopar looks like and contents of the pack
Tensyopar is a round, biconvex, white tablet with a diameter of 14 mm and a height of 7 mm, with a score line on one side. The tablets are supplied in PVC-aluminium blisters, in packages containing 20, 30 or 50 tablets.

Marketing Authorisation Holder
Tactica Pharmaceuticals Sp. z o.o.
Królowej Jadwigi Street 148a/1a
30-212 Kraków
Phone: +48 889 388 538

Manufacturer
Faes Farma, S.A.
Maximo Agirre Kalea, 14
48940 Leioa (Bizkaia)
Spain
or
Faes Farma, S.A.
Parque Científico y Tecnológico de Bizkaia
Ibaizabal Bidea, Edificio 901
48160 Derio (Bizkaia)
Spain