Muscoril

Patient Information Leaflet

MuscoRil 4 mg hard capsules, 8 mg orodispersible tablets

Tiocolchicoside
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

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

Contents of this leaflet:

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

1. What MuscoRil is and what it is used for

This medicine is a muscle relaxant. It is used in adults and adolescents from the age of 16 to help treat painful muscle spasms. It should be used for acute conditions related to the spine.

2. What you need to know before taking MuscoRil

Do not take MuscoRil if:

• you are allergic to tiocolchicoside or to any of the other ingredients of this medicine (listed in section 6);
• you have a condition characterized by loss of muscle control and movement (flaccid paralysis);
• you suffer from muscle weakness (muscular hypotonia);
• you are pregnant, may become pregnant, or suspect you might be pregnant (see "Pregnancy, breastfeeding and fertility");
• you are breastfeeding (see "Fertility, pregnancy and breastfeeding");
• you are a woman of childbearing age 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 or pharmacist before taking MuscoRil.
If you experience symptoms that may indicate liver damage during treatment with MuscoRil (for example, loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, itching), you must stop taking/using MuscoRil and consult your doctor immediately if any of these symptoms occur.
If you develop diarrhoea, contact your doctor, who will decide whether to reduce the dose.
Take this medicine with caution and inform your doctor if you have epileptic seizures or are at risk of seizures, as MuscoRil may worsen these conditions.
Strictly follow the dosage and duration of treatment indicated in section 3. Do not take this medicine at higher doses or for longer than 7 days. This is because one of the substances formed in the body after taking tiocolchicoside 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 possible risk factor for cancer and could harm the foetus and impair male fertility. Speak to your doctor if you have further questions.
Your doctor will advise you on the need for an effective contraceptive method and the potential risks in case of pregnancy (see "Do not use MuscoRil" and "Pregnancy, breastfeeding and fertility").

Children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age.

Other medicines and MuscoRil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No disturbances (interactions) are known when this medicine is taken together with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you might be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if:

• you are pregnant, may become pregnant, or suspect you might be pregnant (see "Do not use MuscoRil");
• you are breastfeeding, because this medicine passes into breast milk (see "Do not use MuscoRil");
• you are a woman of childbearing age who is not using an effective contraceptive method or a man who is not using effective contraceptive measures (see "Do not use MuscoRil"). This medicine can cause harm to the unborn child.

Contraception in women and men
Women who are able to become pregnant must use an effective contraceptive method during treatment with MuscoRil and for 1 month after stopping treatment.
MuscoRil and its metabolites may cause harm to unborn children if used during pregnancy. If you become pregnant while taking MuscoRil or suspect you are pregnant, seek immediate medical advice.
Men must use effective contraception and be advised not to father a child during treatment with MuscoRil and for 3 months after stopping treatment (see "Do not use MuscoRil").

Driving and using machines
This medicine may cause drowsiness. Therefore, avoid driving or operating machinery while taking this medicine.

MuscoRil capsules contain lactose
This medicine contains a type of sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

MuscoRil tablets contain aspartame
This medicine contains 7.60 mg of aspartame (E 951) per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot properly eliminate it.

3. How to take MuscoRil

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended and maximum dose is 8 mg every 12 hours (i.e. 16 mg per day). The duration of
treatment is limited to 7 consecutive days.
Do not exceed the recommended doses or the recommended duration of treatment.
This medicine must not be taken for more than 7 consecutive days (see section 2 "Warnings and precautions").
How to take MuscoRil 8 mg orodispersible tablets: allow the tablet to dissolve in the mouth, with or
without water.
Use in children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age.
If you take more MuscoRil than you should
If you accidentally take more MuscoRil than you should, contact your doctor, pharmacist, or
nurse.
If you forget to take MuscoRil
Do not take a double dose to make up for the missed 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 everybody gets 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.

Rare (may affect up to 1 in 1000 people)

• skin irritations (urticaria);
• agitation and clouding of consciousness (transient mental confusion);
• pain and burning in the throat, chest and/or stomach (pyrosis).

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

• lowering of blood pressure (hypotension).

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

• seizures (See section 2 "Warnings and precautions");
• liver inflammation (hepatitis) (See section 2 "Warnings and precautions");
• swelling of limbs, face, lips, throat and/or tongue (angioedema), severe allergic reactions (anaphylactic shock).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 MuscoRil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and applies to the product in its original
unopened packaging stored correctly.
Store below 30 °C.
Do not dispose of any medicine 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 MuscoRil 4 mg hard capsules contain

• The active substance is tiocolchicoside. Each capsule contains 4 mg of tiocolchicoside.
• The other ingredients are monohydrate lactose, maize starch, magnesium stearate, excipient of the shell: gelatin (transparent capsule).

What MuscoRil 8 mg orodispersible tablets contain

• The active substance is tiocolchicoside. Each tablet contains 8 mg of tiocolchicoside.
• The other ingredients are crospovidone, aspartame, mannitol, magnesium stearate.

Description of the appearance of MuscoRil and pack contents
MuscoRil 4 mg hard capsules: pack containing 30 capsules.
MuscoRil 8 mg orodispersible tablets: pack containing 14 tablets.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano - Italy.

Manufacturers
MuscoRil 4 mg hard capsules
Famar Health Care Services Madrid, S.A.U.– Avda. Leganés 62, 28923 Alcorcón - Madrid
(Spain)

MuscoRil 8 mg orodispersible tablets
Famar Health Care Services Madrid, S.A.U.– Avda. Leganés 62, 28923 Alcorcón - Madrid
(Spain)

Package leaflet: Information for the user

MuscoRil 4 mg/2 ml solution for intramuscular injection

Tiocolchicoside
Please read this leaflet carefully before 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What MuscoRil is and what it is used for

This medicine is a muscle relaxant. It is used in adults and adolescents aged 16 years and older to help treat painful muscle spasms. It should be used for acute conditions related to the spine.

2. What you need to know before using MuscoRil

Do not use MuscoRil if:

• you are allergic to tiocolchicoside or to any of the other ingredients of this medicine (listed in section 6);
• you have a condition characterised by loss of muscle control and movement (flaccid paralysis);
• you suffer from muscle weakness (muscular hypotonia);
• you are pregnant, may become pregnant, or suspect you might be pregnant (see "Pregnancy, breastfeeding and fertility");
• you are breastfeeding (see "Fertility, pregnancy and breastfeeding");
• you are a woman of childbearing age 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 MuscoRil.
If you experience symptoms that may indicate liver damage during treatment with MuscoRil (for example, loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, itching), you must stop taking/using MuscoRil and contact your doctor immediately if any of these symptoms occur.
Use this medicine with caution and inform your doctor if you have seizures or are at risk of seizures, as MuscoRil could worsen these conditions.
After injection of MuscoRil, your doctor should monitor you closely, as a temporary loss of consciousness (vasovagal syncope) may 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 could 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 possible risk factor for cancer and could harm the foetus and impair male fertility. Consult your doctor if you have any 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 MuscoRil" and "Pregnancy, breastfeeding and fertility").

Children and adolescents
Do not administer this medicine to children and adolescents under 16 years of age.

Other medicines and MuscoRil
Inform your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
No disturbances (interactions) are known when this medicine is used together with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist or nurse for advice before using this medicine.
Do not use this medicine if:

• you are pregnant, may become pregnant, or suspect you might be pregnant (see "Do not use MuscoRil");
• you are breastfeeding, because this medicine passes into breast milk (see "Do not use MuscoRil");
• you are a woman of childbearing age who is not using an effective contraceptive method, or a man who is not using effective contraceptive measures (see "Do not use MuscoRil"). This medicine may harm the unborn child.

Contraception in women and men
Women who are able to become pregnant must use an effective contraceptive method during treatment with MuscoRil and for 1 month after the end of treatment.
MuscoRil and its metabolites may cause harm to unborn children if used during pregnancy. If you are pregnant or become pregnant while being treated with MuscoRil, seek immediate medical advice.
Men must use effective contraceptive measures and must be advised not to father a child during treatment with MuscoRil and for 3 months after stopping treatment (see "Do not use MuscoRil").

Driving and using machines
This medicine may cause drowsiness. Therefore, avoid driving or operating machinery while taking this medicine.

MuscoRil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically 'sodium-free'.

3. How to use MuscoRil

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine must be administered by an 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.

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

If you forget to use MuscoRil
Do not use a double dose to make up for the forgotten dose.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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;
• allergic skin reactions.
  Rare (may affect up to 1 in 1,000 people)
• skin irritations (urticaria);
• restlessness and transient mental confusion (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)
• swelling of the limbs, face, lips, throat and/or tongue (angioedema), severe allergic reactions (anaphylactic shock);
• malaise which may be associated with loss of consciousness (vasovagal syncope) within minutes after administration, seizures (See section 2 “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 darkening and death of the skin and underlying tissues surrounding the injection site, which then heal with scarring; this condition is also known as Nicolau syndrome.

Reporting of side effects
If you get any side effects, 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 MuscoRil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and to the product in its original packaging
intact and properly stored.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 MuscoRil contains

• The active substance is tiocolchicoside. Each vial contains 4 mg of tiocolchicoside.
• The other ingredients are sodium chloride, hydrochloric acid 1M, and water for injections.

Description of the appearance of MuscoRil and contents of the pack
Carton pack containing 6 vials of 2 ml.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.
Manufacturers
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A. - Via Morolense 87 - 03013 Ferentino (FR) - Italy.
Doppel Farmaceutici S.r.l. - Via Volturno 48 - Quinto De’ Stampi - 20089 Rozzano (MI) - Italy.
How to open the vial

To open, hold the vial vertically in the position shown in the figure.

Push backwards the top part of the vial as shown in the figure.