Package leaflet: Information for the patient

Tizagelan 2 mg tablets, 4 mg tablets

tizanidine
Equivalent medicinal product
Please read this leaflet carefully before taking 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 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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tizagelan is and what it is used for
What you need to know before taking Tizagelan
How to take Tizagelan
Possible side effects
How to store Tizagelan
Contents of the pack and other information

1. What Tizagelan is and what it is used for

Tizagelan belongs to a group of medicines called skeletal muscle relaxants.
Tizagelan may be prescribed by your doctor for muscle spasms caused by certain conditions of the
spinal column or as a result of surgery on the musculoskeletal system (for
example, the vertebrae or hip joint).
Tizagelan may also be prescribed for muscle spasms resulting from disorders of the nervous system, such as multiple sclerosis and after a stroke.

2. What you need to know before taking Tizagelan

Do not take Tizagelan

if you are allergic to tizanidine or to any of the other ingredients of this medicine (listed in section 6).
if you have severely impaired liver function.
if you are taking certain medicines containing fluvoxamine (used to treat depression) or ciprofloxacin (an antibiotic) (see also “Other medicines and Tizagelan”).

Warnings and precautions
Talk to your doctor before taking Tizagelan,

if you have severe kidney disease. A lower dose may be required.
if you have heart problems such as coronary artery disease.
if you have liver problems. Your doctor may periodically monitor your liver enzymes, especially when taking higher doses. Stop taking Tizagelan and contact your doctor immediately if your skin or the whites of your eyes turn yellow (“jaundice”), or if you develop unexplained nausea, loss of appetite, or fatigue.
if you have kidney problems.

Children and adolescents
Tizagelan is not recommended in children and adolescents under 18 years of age because
experience with tizanidine in this patient group is limited.

Other medicines and Tizagelan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Tizagelan must not be taken together with fluvoxamine (used to treat depression) or ciprofloxacin (an antibiotic) (see “Do not take Tizagelan”).
Inform your doctor or pharmacist especially if you are taking

any medicine to treat abnormal heart rhythm, such as amiodarone, mexiletine, propafenone, or verapamil.
cimetidine or famotidine (for indigestion and peptic ulcer).
certain antibiotics, such as rifampicin, or so-called “fluoroquinolones” (such as enoxacin, pefloxacin, norfloxacin).
rofecoxib, a pain reliever.
aciclovir, an antiviral drug.
oral contraceptives. You may respond to a lower dose of Tizagelan if you are taking the contraceptive pill.
ticlopidine (to prevent blood clots).
any medicine for high blood pressure, including diuretics.
beta-blockers, for example atenolol, propranolol.
digoxin (used to treat congestive heart failure and heart rhythm problems).
any sedatives (sleeping pills or medicines for anxiety).
any other medicine which, when taken with tizanidine, could affect heart rhythm. Check with your doctor or pharmacist.

Tizagelan with food, drinks and alcohol
Tizagelan can be taken with or without food.
Do not take Tizagelan with alcohol, as it may increase the sedative effect of tizanidine.

Tizagelan and cigarette smoking
Cigarette smoking may reduce the effect of tizanidine.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor before taking this medicine.
Tizagelan is not recommended during pregnancy or breastfeeding, as the effects of
Tizagelan on pregnancy, the unborn child, or the newborn infant are unknown. Your doctor will decide whether you should take Tizagelan.

Driving and using machines
Tizagelan may cause drowsiness and dizziness. This may impair your ability to drive or
operate tools or machinery. You should not drive or use machines until you know how this medicine affects you.

Tizagelan contains sucrose and lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Tizagelan

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
For skeletal muscle cramps following surgical procedures and spinal disorders
The recommended dose for adults is 2–4 mg three times daily.
In more severe cases, an additional dose of 2–4 mg may be required. This additional dose should be taken late in the evening.
For muscle cramps due to disorders of the nervous system
The usual initial dose for adults is 2 mg three times daily.
Subsequently, the dose may be gradually increased up to 12–24 mg, divided into 3–4 equal doses per day.
The maximum daily dose is 36 mg.
Use in children and adolescents up to 18 years of age
Tizagelan must not be taken by children, as its use in children has not been sufficiently evaluated.
Elderly (65 years and older)
Experience with the use of Tizagelan in the elderly is limited. In addition, renal function may be impaired in elderly patients. Therefore, Tizagelan should be used with caution in this patient group.
How to take Tizagelan
Tizagelan is for oral use.
The tablets should be swallowed with a glass of water.
Tizagelan may be taken with or without food.
If you feel that Tizagelan is too strong or too weak, consult your doctor or pharmacist.
The tablet may be divided into equal doses.
If you take more Tizagelan than you should
If you (or someone else) take too many tablets, or if you think a child has ingested one of the tablets, contact the nearest emergency department or your doctor immediately.
Overdose may cause nausea, vomiting, low blood pressure, slow or irregular heartbeat, dizziness, pinpoint pupils, breathing difficulties, coma, restlessness, or drowsiness.
If you forget to take Tizagelan
If you forget to take one or more doses, make sure to take only your usual number of tablets at the next scheduled dose. Do not take a double dose to make up for the missed dose.
If you stop taking Tizagelan
Do not stop taking Tizagelan unless your doctor tells you to. Treatment with Tizagelan should be discontinued gradually, especially if you have been taking a high dose, unless your doctor has instructed otherwise. Stopping treatment suddenly may cause effects such as increased heart rate and high blood pressure.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
At low doses, such as those recommended for relief of painful muscle spasms, side effects are usually mild and transient.
At higher doses, recommended for the treatment of spasticity, side effects occur more frequently and are more pronounced, but are rarely so severe as to require discontinuation of treatment.

The following side effects have been reported:

Very common (may affect more than 1 in 10 people)

Difficulty sleeping or falling asleep
Dry mouth, gastrointestinal disturbances
Muscle weakness

Common (may affect up to 1 in 10 people)

Drowsiness, lethargy, dizziness, fatigue
Slow or fast heartbeat
Low or reduced blood pressure
Nausea

Uncommon (may affect up to 1 in 100 people)

Increased levels of liver enzymes in the blood

Not known (frequency cannot be estimated from the available data)

Infections, blocked or runny nose, throat infections
Allergic reactions:
o Hives
o Severe, life-threatening allergic reaction requiring immediate medical treatment. The reaction may include extremely low blood pressure, swelling of the throat, breathing difficulties, and loss of consciousness.
Confusion, nervousness, hallucinations (seeing and/or hearing things that are not real)
Headache
Difficulty controlling movements, involuntary muscle movements, difficulty speaking
Fainting
Sensation of spinning (dizziness)
Difficulty focusing vision, blurred vision
Irregular heart rhythms
Vomiting, abdominal pain, constipation
Liver infection or liver failure
Itching, skin rash, skin infection
Urinary tract infection
Unusually frequent passage of relatively small amounts of urine
Loss of appetite
Feeling of weakness, withdrawal syndrome, flu-like illness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 Tizagelan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 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 Tizagelan contains

The active substance is tizanidine. Each tablet contains 2 mg of tizanidine (as 2.29 mg of tizanidine hydrochloride) / 4 mg of tizanidine (as 4.57 mg of tizanidine hydrochloride).
The other components are monohydrate lactose, pregelatinized starch (maize), macrogol 4000, stearic acid, sucrose, magnesium stearate.

Description of the appearance of Tizagelan and pack contents
Tizagelan 2 mg tablets are round, biconvex tablets, white to slightly yellowish in colour, with a scored line on one side and a diameter of approximately 8 mm.
Tizagelan 4 mg tablets are round, biconvex tablets, white to slightly yellowish in colour, with a scored line on one side and a diameter of approximately 8 mm.
Tizagelan is available in PVC/PVdC/PVC-aluminium blisters containing 10, 30, 60, 90, 100 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Marketing Authorisation Holder in Italy:
G.L. Pharma Italy S.r.l., [email protected]

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Netherlands, United Kingdom (Northern Ireland): Tizagelan 2 mg tablets
Tizagelan 4 mg tablets
Austria: Tizagelan 2 mg Tabletten
Tizagelan 4 mg Tabletten
Finland: Tizagelan 2 mg tabletit
Tizagelan 4 mg tabletit
Hungary: Tizagelan 2 mg tabletta
Tizagelan 4 mg tabletta
Italy, Poland: Tizagelan