Tensiopar

Package Leaflet: Information for the Patient

Tensyopar 380 mg+300 mg Tablets

Metocarbamol+Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Tensyopar and what is it used for
• 2. Important information before taking Tensyopar
• 3. How to take Tensyopar
• 4. Possible side effects
• 5. How to store Tensyopar
• 6. Contents of the pack and other information

1. What is Tensyopar and what is it used for

This medicinal product is a combination of a pain reliever and antipyretic (reducing pain and fever) and a muscle relaxant.
This medicinal product relieves muscle pain and stiffness and treats painful muscle spasms.
Treatment with metocarbamol should be as short as possible. When the pain subsides, the doctor will stop the administration of this medicine. The duration of treatment depends on the symptoms, but should not exceed 30 days.

2. Important information before taking Tensyopar

When not to take Tensyopar:

• if the patient is allergic to metocarbamol, 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 had brain damage or been in a coma,
• if the patient has epilepsy or has seizures,
• if the patient has muscle weakness (or a disease called myasthenia).

Warnings and precautions

Do not take higher doses than recommended (see section 3. How to take Tensyopar).
The patient should make sure they are not taking other medicines containing paracetamol at the same time (e.g. cold medicines or other fever-reducing medicines).

Before starting Tensyopar, the patient should discuss with their doctor or pharmacist:

• if the patient regularly consumes alcohol (more than three alcoholic drinks per day);
• if the patient has chronic alcoholism, they should be cautious 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 time between doses, and emphasize the importance of not prolonging treatment beyond the necessary time;
• if the patient has heart or lung disease or anemia;
• if the patient has asthma with aspirin hypersensitivity;
• if the patient is being treated with antiepileptic drugs. See below: Tensyopar and other medicines.

Concomitant use reduces the effectiveness and increases the hepatotoxicity of paracetamol, especially in cases of high-dose paracetamol treatment.
During treatment with this medicine, the patient should immediately inform their doctor if they experience severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when the patient is also taking flucloxacillin (an antibiotic). Serious metabolic acidosis (a blood and fluid disorder) has been reported in patients who take paracetamol regularly for a longer period or when taking paracetamol 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 their doctor that they are taking this medicine, as it may affect the results.
Paracetamol may affect the analytical determination of uric acid and glucose.

Tensyopar and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Metocarbamol may interact with the following medicines:

• barbiturates (used to treat epilepsy or to help with sleep),
• appetite suppressants (used to support weight loss),
• anticholinergic medicines (used to treat spasms or painful spasms of the intestines and urinary bladder or motion sickness),
• psychotropic medicines (used to treat anxiety, depression, or other mental illnesses),
• anesthetics (if the patient is to be anesthetized for any reason, they should tell their doctor or dentist that they are taking this medicine),
• anticholinesterase (used to treat myasthenia),

Paracetamol may interact with the following medicines:

• oral anticoagulants (used to treat blood clotting disorders),
• antiepileptic medicines (used to treat seizures),
• antibiotics (chloramphenicol),
• contraceptives,
• diuretics (used to increase urine output),
• isoniazid (used to treat tuberculosis),
• metoclopramide and domperidone (used to treat vomiting),
• probenecid (used to treat gout),
• propranolol (used to treat high blood pressure, heart rhythm disorders),
• rifampicin (used to treat tuberculosis),
• anticholinergic medicines (used to treat spasms or painful spasms of the intestines and urinary bladder),
• zidovudine (used to treat HIV infections),
• cholestyramine (used to reduce blood cholesterol levels), The patient should inform their doctor or pharmacist if they are taking: - flucloxacillin (an antibiotic) due to serious blood and fluid disorders (called metabolic acidosis), which requires emergency treatment (see section 2).

Do not take this medicine with other pain relievers (analgesics) without consulting a doctor.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

Taking Tensyopar with food, drink, and alcohol

While taking this medicine, the patient should avoid drinking alcohol. Alcohol may enhance the depressant effect of metocarbamol on the central nervous system. Taking paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, liquor...) may cause liver damage.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor.
Pregnancy
This medicine should not be used during pregnancy. If the patient becomes pregnant during treatment, they should immediately consult their doctor, who will adjust the treatment according to their condition.
Breastfeeding
Women who are breastfeeding should consult their doctor before taking this medicine. The doctor will discuss with the patient whether they should breastfeed their child. Metocarbamol and/or its metabolites have been detected in dog milk, but it is not known whether metocarbamol or its metabolites pass into human milk. Paracetamol passes into human milk, but not in clinically significant amounts.

Driving and using machines

The patient may feel drowsy while taking this medicine, so they should not drive or operate machinery until they have checked that the medicine does not affect them. This is especially important if the patient has consumed alcohol or is taking other medicines that can also cause drowsiness.

3. How to take Tensyopar

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor.
The recommended dose is:
Adults:
The recommended dose is 2 tablets, 4 to 6 times a day, 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 4 times a day.
Patients with kidney/liver problems
They may require longer intervals between doses.
The patient should strictly follow the doctor's instructions (see section 2 Important information before taking Tensyopar).
Depending on the severity of kidney function disorders, 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 in 24 hours.

Use in children and adolescents

This medicine should not be used in children or adolescents under 18 years of age due to the lack of data on safety and efficacy in this population.
This medicine is administered orally.
The dividing line on the tablet is only to facilitate breaking it to make it easier to swallow.
The tablets should be swallowed without chewing, with a sufficient 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 spasms. After they subside, the doctor will discontinue the use of the medicine.
The patient should remember to take their medicine. Do not take a higher dose than recommended.
If the patient feels that the effect of Tensyopar is too strong or too weak, they should contact their doctor or pharmacist.

Overdose of Tensyopar

In case of overdose, the patient should immediately contact their doctor, pharmacist, or hospital emergency department. They should take the Tensyopar packaging with them.

Missed dose of Tensyopar

Do nottake a double dose to make up for a missed dose of Tensyopar. If the patient is sure they have missed a tablet at the right time, they should take it as soon as possible and then return to their usual dosing schedule. Before taking the next tablet, they should always wait 4 hours. In case of doubts, the patient should consult their doctor or hospital.

Stopping Tensyopar

In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following reactions occur, the patient should stop treatment and immediately inform their doctor.

• Allergic reactions from simple skin rash or hives to more severe reactions, such as anaphylactic reaction or angioedema (rash, itching, swelling of limbs, face, lips, mouth, or throat, which may cause difficulty 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, the patient should immediately contact their doctor, as this may indicate changes in white blood cells or platelets, reducing the resistance to infections;
• Seizures or fainting.

The following side effects may occur rarely (may affect up to 1 in 1000 people):

• Headache, dizziness, or feeling dizzy;
• Conjunctivitis with nasal congestion;
• Low blood pressure, metallic taste in the mouth, increased liver transaminase activity;
• Fever, malaise.

The following side effects may occur very rarely (may affect up to 1 in 10,000 people):

• Nausea, vomiting;
• Nervousness, anxiety, disorientation, tremors, drowsiness, blurred vision, nystagmus (rapid, involuntary eye movements);
• Low blood sugar, decreased heart rate, flushing;
• Toxic effect on the kidneys (dark urine color);
• Shortness of breath.

The following side effects have been reported, but their frequency cannot be estimated from the available data (frequency not known):

• Mild muscle coordination disorders, memory loss, dizziness, insomnia, double vision;
• Heartburn, dry mouth, fatigue, diarrhea.
• A serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Tensyopar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tensyopar 380 mg/300 mg tablets contain

• The active substances are metocarbamol and paracetamol. Each tablet contains 380 mg of metocarbamol and 300 mg of paracetamol.
• The other ingredients are: stearic acid, maize starch, sodium croscarmellose, magnesium stearate, silica, colloidal anhydrous, povidone K-30, glycerol distearate (type I), sodium carboxymethylcellulose (type A), and talc.

What Tensyopar looks like and contents of the pack

Tensyopar 380 mg+300 mg tablets are round, biconvex, white tablets, 14 mm in diameter and 7 mm in height, with a dividing line on one side. They are available in PVC-aluminum blisters, in packs of 20, 30, or 50 tablets.

Marketing authorization holder

Tactica Pharmaceuticals Sp. z o.o.
ul. Królowej Jadwigi 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
Date of last revision of the leaflet:05/2025