Muscoflex

Package leaflet: Information for the user

MUSCOFLEX 2 mg/ml solution for intramuscular injection

Tiocolchicoside
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What MUSCOFLEX is and what it is used for
2. What you need to know before you use MUSCOFLEX
3. How to use MUSCOFLEX
4. Possible side effects
5. How to store MUSCOFLEX
6. Contents of the pack and other information

1. What MUSCOFLEX is and what it is used for

This medicinal product is a muscle relaxant. It is used in adults and adolescents from 16 years of age onwards, as an adjunctive treatment for painful muscle spasms. It should be used for acute conditions related to the spine.

2. What you need to know before using MUSCOFLEX

Do not use MUSCOFLEX if:

• you are allergic to tiocolchicoside or to any of the other ingredients of this medicine (listed in section 6);
• you suffer from flaccid paralysis, a condition characterized by loss of muscle control and movement;
• you suffer from muscle weakness (muscular hypotonia);
• you are pregnant, suspect you may be pregnant, or could become pregnant (see "Pregnancy, breastfeeding and fertility");
• you are breastfeeding (see "Pregnancy, breastfeeding and fertility");
• you are a woman of childbearing potential who is not using an effective contraceptive method (during treatment and for one month after stopping treatment);
• you are a man who is not using effective contraceptive measures (during treatment and for three months after stopping treatment).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using MUSCOFLEX.
You must inform your doctor if you experience any of the following symptoms:

• epileptic seizures
• convulsions

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Use this medicine with caution and inform your doctor if you have epilepsy or are at risk of convulsions,
as MUSCOFLEX could worsen these conditions.
After administration of MUSCOFLEX, your doctor should closely monitor you, as temporary loss of consciousness (vasovagal syncope) may occur.
Cases of liver inflammation (cytolytic and cholestatic hepatitis) have been reported during treatment with this medicine. Some of these cases have been fatal (fulminant hepatitis) when
MUSCOFLEX was administered together with other medicines used to relieve pain (NSAIDs,
paracetamol).
If you notice symptoms that may indicate liver damage during treatment with Muscoflex (for example,
loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, itching), you must
discontinue the use of Muscoflex and consult your doctor immediately if any of
these symptoms occur.
Strictly follow the doses and duration of treatment indicated in section 3. Do not use this
medicine at higher doses or for longer than 5 days. This is because one of the substances formed in the body after taking tiocolchicoside at high doses may cause damage to certain cells (abnormal number of
chromosomes). This has been demonstrated in animal studies and laboratory studies. In humans, this
type of cellular damage is a risk factor for cancer, may harm the unborn child, and may impair male fertility.
Talk to your doctor if you have further questions.
Your doctor will advise you on the need for an effective contraceptive method and on the potential risks in case of pregnancy (see "Do not use MUSCOFLEX" and "Pregnance, breastfeeding and fertility").
Children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age due to safety concerns.
Other medicines and MUSCOFLEX
Inform your doctor, pharmacist, or nurse if you are currently taking, have recently taken, or might take any other medicines.
No interaction studies with other medicines have been conducted.
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Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, please consult your doctor, pharmacist, or nurse before using this medicine.
Do not use this medicine if:

• you are pregnant, suspect you may be pregnant, or could become pregnant (see "Do not use MUSCOFLEX");
• you are breastfeeding, as this medicine passes into breast milk (see "Do not use MUSCOFLEX");
• you are a woman of childbearing potential who is not using an effective contraceptive method or a man who is not using effective contraceptive measures (see "Do not use MUSCOFLEX").

This medicine may cause harm to the unborn child.
Contraception in women and men
Women who are capable of becoming pregnant must use an effective contraceptive method
during treatment with MUSCOFLEX and for 1 month after completion of treatment.
MUSCOFLEX and its metabolites may cause harm to unborn children if used during pregnancy. If you are pregnant or become pregnant while being treated with MUSCOFLEX, seek immediate medical advice.
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Men must use effective contraceptive measures and must be advised not to father a child during treatment with MUSCOFLEX and for 3 months after stopping treatment (see "Do not use MUSCOFLEX").
MUSCOFLEX may cause male fertility problems due to potential damage to sperm cells (abnormal number of chromosomes). This is based on laboratory studies (see section 2 "Warnings and precautions").
Driving and using machines
This medicine may cause drowsiness. Therefore, if this occurs, avoid driving or operating machinery.
MUSCOFLEX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to use MUSCOFLEX

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

This medicine must be administered by injection into a muscle (intramuscular use).

The recommended and maximum dose is 4 mg every 12 hours (i.e. 8 mg per day). The duration of treatment is limited to 5 consecutive days.

Do not exceed the recommended doses or the recommended duration of treatment.

This medicine must not be used for more than 5 consecutive days (see section 2, "Warnings and precautions").

Use in children and adolescents

Do not administer this medicine to children and adolescents under 16 years of age due to safety concerns.

If you use more MUSCOFLEX than you should

If you accidentally use more MUSCOFLEX than you should, contact your doctor, pharmacist, or nurse.

If you forget to use MUSCOFLEX

Do not use a double dose to make up for the forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:

Common (may affect up to 1 in 10 people)

• drowsiness;
• diarrhoea, stomach pain (gastralgia).

Uncommon (may affect up to 1 in 100 people)

• itching;
• nausea, vomiting;
• skin allergic reactions.

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

• skin rash (urticaria);
• agitation, confusion and impaired consciousness (transient obnubilation);
• pain and burning in the throat, chest and stomach (pyrosis).

Very rare (may affect up to 1 in 10,000 people)

• low blood pressure (hypotension).

Frequency not known (frequency cannot be estimated from the available data)

• severe allergic reactions: swelling of the limbs, face, lips, mouth, tongue and/or throat, which may cause breathing or swallowing difficulties (angioedema), sudden severe allergic reaction potentially leading to life-threatening shock (anaphylactic shock);
• feeling unwell, possibly associated with loss of consciousness (vasovagal syncope) within minutes after administration, seizures (see section “Warnings and precautions”);
• liver inflammation (hepatitis) (see section 2 “Warnings and precautions”);
• injection site reactions, including pain, redness, swelling, itching, spots. These reactions may worsen with tissue darkening and death of the skin and underlying tissues surrounding the injection site, followed by healing with scarring; this condition is also known as Nicolau syndrome.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MUSCOFLEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MUSCOFLEX contains

• The active substance is tiocolchicoside. Each vial contains 4 mg of tiocolchicoside.
• The other components are sodium chloride, water for injectable preparations.

Description of the appearance of MUSCOFLEX and contents of the pack
Pack containing 6 vials of 2 ml each.
Marketing Authorization Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ) – Italy
Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello, 15 - 00071 Pomezia (RM) - Italy
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