DROMOS 500 mg Coated Tablet

Зміст інструкції

1. Dromos 300 mg 300 mg/5 ml powder and solvent for injectable solution
   1. What is Dromos and what is it used for
   2. What you need to know before using Dromos
   3. How to use Dromos
   4. Possible side effects
   5. How to store Dromos
   6. Contents of the pack and other information
2. Dromos 500 mg tablets
   1. What is Dromos and what is it used for
   2. What you need to know before using Dromos
   3. How to use Dromos
   4. Possible side effects
   5. How to store Dromos
   6. Contents of the pack and other information

Dromos 300 mg 300 mg/5 ml powder and solvent for injectable solution

L-propionyl carnitine hydrochloride

Read this leaflet carefully before using 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Dromos and what is it used for

Dromos contains the active ingredient L-propionyl carnitine hydrochloride.
L-propionyl carnitine acts on the cells of the muscles and heart, where it promotes the production of
energy, and exerts a protective action on blood vessels.
Dromos is indicated for the treatment of:

• diseases of the arteries of the lower limbs with narrowing or occlusion of the same (obliterating arterial diseases of the lower limbs);
• severe chronic heart failure (chronic congestive heart failure), to increase exercise tolerance.

2. What you need to know before using Dromos

Do not use Dromos

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

Warnings and precautions
Talk to your doctor or pharmacist before using Dromos.
Tell your doctor:

• if you have moderate or severe kidney failure, as it may be necessary to reduce the dose of Dromos.

Other medicines and Dromos
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No incompatibilities have been observed when administering L-propionyl carnitine with digitalis,
vasodilators, diuretics, oral antidiabetics.

Pregnancy, breastfeeding and fertility
There are no studies in women during pregnancy or breastfeeding. If you are pregnant, if
you suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, Dromos will only be prescribed in cases of actual need and under
direct medical supervision.
There are no studies on fertility.

Driving and operating machinery
Dromos does not impair the ability to drive or operate machinery.

Dromos vials contains sodium
This medicine contains 1.7 mmol (or 38.7 mg) of sodium per vial. This should be taken into
account in people with reduced kidney function or who are following a low-sodium
diet.

3. How to use Dromos

Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.

Dromos 300 mg/5 ml powder and solvent for injectable solution
If you have peripheral arterial disease associated with pain at rest, skin changes
(skin dystrophies) or trophic lesions, or if you have severe heart failure (refractory
congestive heart failure), your doctor may prescribe intravenous treatment with 300-
600 mg per day of Dromos 300 mg vials for 7-20 days. The administration of Dromos intravenously
must be carried out slowly over 3 minutes.
After reconstitution, the solution of Dromos 300 mg vials should normally be used immediately.
The reconstituted product can be administered during therapy, slow administration into a
vein (infusion) together with glucose or physiological solutions.
The solvent has a pH value of approximately 10 and must be used exclusively for the reconstitution of
Dromos.
Dromos tablets can be used as maintenance therapy, at a dose of 2 tablets
of 500 mg, 2-3 times a day, after treatment with Dromos intravenously.

Use in patients with kidney problems
If you have moderate or severe kidney failure, your doctor may reduce the dose of Dromos.

If you use more Dromos than you should
In case of accidental ingestion or use of an excessive dose of Dromos, immediately
inform your doctor or go to the nearest hospital.
To date, no cases of accidental ingestion or use of an excessive dose of Dromos are known.

If you forget to use Dromos
Do not use a double dose to make up for a missed dose.

If you stop using Dromos
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• lung infection, influenza, infections
• headache, dizziness
• increased awareness of your heartbeat (palpitations), sudden loss of consciousness (syncope)
• high blood pressure (hypertension), low blood pressure (hypotension)
• difficulty breathing (dyspnea)
• stomach pain, abdominal pain
• difficulty digesting (dyspepsia), diarrhea
• skin rash
• back pain
• feeling tired, pain at the injection site*, chest pain

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

• drowsiness*
• inflammation of a vein (phlebitis*)
• nausea, vomiting*

* After intravenous treatment
A small number of patients treated in clinical studies with DROMOS reported progression of underlying peripheral arterial disease.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Dromos

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after Scad.. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Dromos contains
Dromos 300 mg/5 ml powder and solvent for injectable solution

• One vial of powder for solution for injection contains: The active ingredient is L-propionyl carnitine HCl. Each vial contains 300 mg of L-propionyl carnitine HCl. The other components are mannitol.
• The solvent vial contains disodium phosphate bibasic dihydrate, tromethamine, water for injections.

Description of the appearance of Dromos and contents of the pack
Dromos 300 mg/5 ml powder and solvent for injectable solution
Each pack contains:

• 5 vials of powder (300 mg) + 5 vials of solvent
• 10 vials of powder (300 mg) + 10 vials of solvent

Marketing Authorisation Holder
Alfasigma S.p.A. – Viale Sarca, n. 223 – Milan (MI)

Manufacturer
Alfasigma S.p.A. Via Pontina Km 30,400 00071 Pomezia (RM)

Dromos 500 mg tablets

L-propionyl carnitine hydrochloride

Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Dromos and what is it used for

Dromos contains the active ingredient L-propionyl carnitine hydrochloride.
L-propionyl carnitine acts on the cells of the muscles and heart, where it promotes the production of
energy, and exerts a protective action on blood vessels.
Dromos is indicated for the treatment of:

• diseases of the arteries of the lower limbs with narrowing or occlusion of the same (obliterative arterial diseases of the lower limbs);
• severe chronic heart failure (chronic congestive heart failure), to increase exercise tolerance.

2. What you need to know before using Dromos

Do not use Dromos

• if you are allergic to L-propionyl carnitine 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 Dromos.
Tell your doctor:

• if you have moderate or severe kidney failure, as it may be necessary to reduce the dose of Dromos.

Other medicines and Dromos
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
No incompatibilities have been observed when administering L-propionyl carnitine with digitalis,
vasodilators, diuretics, oral antidiabetics.

Pregnancy, breastfeeding and fertility
There are no studies in women during pregnancy or breastfeeding. If you are pregnant, if
you suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, Dromos will only be prescribed in cases of actual need and under
direct medical supervision.
There are no studies on fertility.

Driving and operating machinery
Dromos does not impair the ability to drive or operate machinery.

3. How to use Dromos

Use this medicine following the instructions of your doctor or pharmacist exactly as given. If you
have any doubts, ask your doctor or pharmacist.
Dromos 500 mg tablets
The recommended dose is 2 tablets of 500 mg, 2-3 times a day, unless otherwise prescribed by
your doctor.

Use in patients with kidney problems
If you have moderate or severe kidney failure, your doctor may reduce the dose of Dromos.

If you use more Dromos than you should
In case of accidental ingestion or use of an excessive dose of Dromos, immediately inform
your doctor or go to the nearest hospital.
To date, there are no known cases of accidental ingestion or use of an excessive dose of Dromos.

If you forget to use Dromos
Do not use a double dose to make up for a missed dose.

If you stop treatment with Dromos
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• lung infection, influenza, infections
• headache, dizziness
• increased awareness of your heartbeat (palpitations), sudden loss of consciousness (syncope)
• high blood pressure (hypertension), low blood pressure (hypotension)
• difficulty breathing (dyspnea)
• stomach pain, abdominal pain
• difficulty digesting (dyspepsia), diarrhea
• skin rash
• back pain
• feeling tired, chest pain

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• nausea

A small number of patients treated in clinical studies with DROMOS have reported progression of underlying peripheral arterial disease.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Dromos

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after Scad.. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Dromos contains
Dromos 500 mg tablets

• The active ingredient is L-propionyl carnitine HCl. Each tablet contains 500 mg of L-propionyl carnitine HCl.
• The other ingredients are microcrystalline cellulose, povidone, crospovidone, magnesium stearate, anhydrous colloidal silica, hypromellose, macrogol 6000, titanium dioxide, talc.

Description of the appearance of Dromos and contents of the pack
Dromos 500 mg tablets
Each pack contains 30 tablets of 500 mg in blisters

Marketing Authorisation Holder
Alfasigma S.p.A. – Viale Sarca, n. 223 – Milan (MI)

Manufacturer
Alfasigma S.p.A. Via Pontina Km 30,400 00071 Pomezia (RM)