Nicetile

Package leaflet: Information for the patient

Nicetile 500 mg gastro-resistant tablets, 500 mg powder for oral solution

L-acetylcarnitine
Please read all of 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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nicetile is and what it is used for

Nicetile contains the active ingredient L-acetylcarnitine. L-acetylcarnitine has a protective,
nutritive, and antioxidant effect on brain cells, spinal cord, and peripheral nerves.
Nicetile is indicated for the treatment of peripheral nerve injuries (trunk and radicular lesions) caused by
mechanical factors or inflammatory processes.

2. What you need to know before taking Nicetile

Do not take Nicetile

• if you are allergic to L-acetylcarnitine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Nicetile.
Oral administration does not require special precautions.

Other medicines and Nicetile
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no interactions are known when Nicetile has been used together with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, particularly during the first trimester, or if you are breastfeeding, your doctor will assess whether the benefits to you clearly outweigh any risks to the fetus/child before prescribing Nicetile.

Driving and using machines
Nicetile does not impair the ability to drive or operate machinery.

Nicetile 500 mg oral solution powder
contains less than 1 mmol (23 mg) of sodium per sachet and per maximum daily dose, i.e. essentially "sodium-free".

3. How to take Nicetile

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 500 mg - 1,500 mg daily, divided into 2 or 3 doses according to your
doctor's prescription.
How to take the oral solution
Nicetile powder for oral solution

• Dissolve the contents of each sachet in half a glass of water and drink it.

If you take more Nicetile than you should
In case of accidental overdose of Nicetile, inform your doctor immediately or go to the nearest hospital.
To date, no cases of accidental overdose of Nicetile have been reported.
If you forget to take Nicetile
Do not take a double dose to make up for a forgotten dose.
If you stop treatment with Nicetile
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Common side effects (may affect from 1 to 10 out of 100 people):

• diarrhoea, nausea

Uncommon side effects (may affect up to 1 in 100 people):

• loss of appetite
• insomnia
• dizziness, headache, skin hypersensitivity to normal stimuli, pain referred to a part of the body, tingling
• abdominal swelling, abdominal pain or upper abdominal pain, constipation, difficulty digesting (dyspepsia), excessive production and passage of intestinal gas, stomach and intestinal disorders, vomiting
• itching, skin rash, abnormal odour of the skin
• joint pain, muscle contractions
• feeling of fatigue, swelling due to excessive accumulation of fluid in peripheral parts of the body, pain

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• inner restlessness manifested by excessive motor activity, tremor
• vertigo
• skin irritation and redness, urticaria
• swelling due to fluid accumulation limited to a part of the body, feeling of malaise

Occasional cases of mild excitement have been reported, which rapidly resolve with dose reduction.

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 Nicetile

Keep this medicine out of the sight and reach of children.
Nicetile tablets and oral solution powder in sachets
Do not store above 25°C.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Nicetile contains
Nicetile gastro-resistant tablets

• The active substance is L-acetylcarnitine. Each tablet contains 590.0 mg of L-acetylcarnitine hydrochloride, equivalent to 500 mg of the base salt.
• The other components are polyvinylpyrrolidone, microcrystalline cellulose, magnesium stearate, cellulose acetate phthalate, diethyl phthalate, dimethicone.

Nicetile powder for oral solution

• The active substance is L-acetylcarnitine. Each sachet contains 590.0 mg of L-acetylcarnitine hydrochloride, equivalent to 500 mg of the base salt.
• The other components are anhydrous colloidal silica, sodium saccharin, hydroxypropylcellulose, tonic water (1 x 1000), mannitol.

Description of the appearance of Nicetile and contents of the pack
Nicetile gastro-resistant tablets
Each pack contains 30 tablets of 500 mg in blisters.
Nicetile powder for oral solution in sachets
Each pack contains 20 sachets of 500 mg oral solution powder.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)
Package leaflet: information for the patient

Nicetile 500 mg/4 mL powder and solvent for injectable solution

Acetyl-L-carnitine
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nicetile is and what it is used for

Nicetile contains the active substance L-acetylcarnitine. L-acetylcarnitine has a protective,
nutritive, and antioxidant effect on the cells of the brain, spinal cord, and peripheral nerves.
Nicetile is indicated for the treatment of peripheral nerve injuries (trunk and radicular lesions) caused by
mechanical factors or inflammatory processes.

2. What you need to know before using Nicetile

Do not use Nicetile

• if you are allergic to L-acetylcarnitine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Nicetile.
After administration of Nicetile, facial flushing with a sensation of warmth may occur.
Other medicines and Nicetile
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
To date, no interactions are known when Nicetile has been used together with other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, especially during the first trimester, or if you are breastfeeding, your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus/infant before prescribing Nicetile.
Driving and using machines
Nicetile does not impair the ability to drive or operate machinery.

3. How to use Nicetile

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 500 mg - 1,500 mg per day, divided into 2 or 3 doses according to the doctor's prescription.
Nicetile can be administered either into a vein or into a muscle. Intravenous administration must be performed slowly.
If you use more Nicetile than you should
If you accidentally ingest or use an excessive dose of Nicetile, inform your doctor immediately or go to the nearest hospital.
To date, no cases of accidental ingestion or overdose of Nicetile have been reported.
If you forget to use Nicetile
Do not take a double dose to make up for the forgotten dose.
If you stop using Nicetile
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Common side effects (may affect from 1 to 10 people in 100):

• diarrhoea, nausea

Uncommon side effects (may affect up to 1 person in 100):

• decreased appetite
• insomnia
• dizziness, headache, skin hypersensitivity to normal stimuli, pain referred to a body area, tingling
• abdominal swelling, abdominal or upper abdominal pain, constipation, difficulty digesting (dyspepsia), excessive production and passage of intestinal gas (flatulence), stomach and intestinal disorders, vomiting
• itching, skin rash, abnormal odour of the skin
• joint pain, muscle contractions
• feeling of fatigue, injection site pain, swelling due to excessive accumulation of fluid in peripheral body parts, pain

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• inner restlessness manifesting as excessive motor activity, tremor
• dizziness
• skin irritation and redness, urticaria
• swelling due to fluid accumulation limited to a body area, feeling of malaise.

Isolated cases of mild excitement have been reported, which rapidly resolve upon dose reduction.

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 Nicetile

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
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.
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. Contents of the pack and other information

What Nicetile contains

• The active substance is L-acetylcarnitine. Each vial contains 500 mg of L-acetylcarnitine.
• The other component is mannitol.
• The solvent vial contains water for injections.

Description of the appearance of Nicetile and contents of the pack
Each pack contains 5 vials of 500 mg powder and 5 ampoules of 4 ml solvent for injectable use,
or 10 vials of 500 mg powder and 10 ampoules of 4 ml solvent for injectable use.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30.400 - 00071 Pomezia (RM)