Dromos

Package leaflet: Information for the patient

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

L-propionyl carnitine hydrochloride
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 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 may 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 Dromos is and what it is 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

1. What Dromos is and what it is used for

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

• diseases of the arteries in the lower limbs characterized by narrowing or blockage (obliterative arteriopathy of the lower limbs);
• severe chronic heart failure (chronic congestive heart failure), to improve exercise tolerance.

2. What you need to know before using Dromos

Do not use Dromos

• if you are allergic to L-propionylcarnitine 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.
Inform your doctor:

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

Other medicines and Dromos
Inform 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-propionylcarnitine with digitalis agents, vasodilators, diuretics, or oral antidiabetics.

Pregnancy, breastfeeding and fertility
There are no studies in women during pregnancy or breastfeeding. If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, Dromos will be prescribed only if clearly needed and under strict medical supervision.
There are no studies on fertility.

Driving and using machines
Dromos does not affect the ability to drive or operate machinery.

Dromos vials contain sodium
This medicine contains 1.7 mmol (or 38.7 mg) of sodium per vial. This should be taken into consideration for patients with impaired renal function or those on a low-sodium diet.

3. How to use Dromos

Use this medicine exactly as directed by your doctor or pharmacist. 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 rest pain, skin disorders (cutaneous dystrophies), or trophic lesions, or if you have severe heart failure (refractory congestive heart failure), your doctor may prescribe an intravenous treatment with 300–600 mg of Dromos 300 mg vials per day for 7–20 days. Administration of Dromos by intravenous route must be performed slowly over a period of 3 minutes.

After reconstitution, the Dromos 300 mg solution should normally be used immediately. The reconstituted product may be administered during therapy as a slow intravenous infusion together with glucose or physiological solutions.

The solvent has a pH of approximately 10 and must be used exclusively for the reconstitution of Dromos.

Dromos tablets may be used as maintenance therapy, at a dose of 2 tablets of 500 mg, 2–3 times daily, following intravenous treatment with Dromos.

Use in patients with kidney problems

If you have moderate or severe renal impairment, your doctor may reduce the dose of Dromos.

If you use more Dromos than you should

In case of accidental ingestion or overdose of Dromos, inform your doctor immediately or go to the nearest hospital.

To date, there have been no reported cases of accidental ingestion or overdose of Dromos.

If you forget to use Dromos

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

If you stop using Dromos

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

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

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

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

* After intravenous administration
A small number of patients treated in clinical studies with DROMOS reported progression of underlying peripheral arterial disease.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via 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 special storage conditions.
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.
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 Dromos contains
Dromos 300 mg/5 ml powder and solvent for injectable solution

• A vial of powder for injectable solution contains: The active substance is L-propionyl carnitine HCl. Each vial contains 300 mg of L-propionyl carnitine HCl. The other component is mannitol.
• The solvent ampoule contains disodium phosphate 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 300 mg powder + 5 solvent ampoules
• 10 vials of 300 mg powder + 10 solvent ampoules

Marketing Authorization Holder
Alfasigma S.p.A. – Viale Sarca, n. 223 – Milano (MI)
Manufacturer
Alfasigma S.p.A. Via Pontina Km 30,400 00071 Pomezia (RM)

Patient information leaflet

Dromos 500 mg tablets

L-propionyl carnitine hydrochloride
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 others, 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, contact 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 taking Dromos
3. How to take Dromos
4. Possible side effects
5. How to store Dromos
6. Contents of the pack and other information

1. What Dromos is and what it is used for

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

• diseases of the arteries in the lower limbs characterized by narrowing or blockage (obliterative arterial disease of the lower limbs);
• severe chronic heart failure (chronic congestive heart failure), to improve exercise tolerance.

2. What you should know before using Dromos

Do not use Dromos

• if you are allergic to L-propionylcarnitine 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.
Inform your doctor:

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

Other medicines and Dromos
Inform 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-propionylcarnitine with digitalis agents, vasodilators, diuretics, or oral antidiabetics.

Pregnancy, breastfeeding and fertility
There are no studies in women during pregnancy or breastfeeding. If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, Dromos will be prescribed only if clearly necessary and under direct medical supervision.
There are no studies on fertility.

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

3. How to use Dromos

Use this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dromos 500 mg tablets
The recommended dose is 2 tablets of 500 mg, 2-3 times daily, unless otherwise prescribed by
your doctor.
Use in patients with kidney problems
If you have moderate or severe renal impairment, your doctor may reduce the dose of Dromos.
If you use more Dromos than you should
In case of accidental ingestion or overdose of Dromos, inform your doctor immediately or go to the nearest hospital.
To date, there have been no reported cases of accidental ingestion or overdose of Dromos.
If you forget to use Dromos
Do not take a double dose to make up for a forgotten dose.
If you stop treatment with Dromos
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 gets them.

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

• lung infection, influenza, infections
• headache, dizziness
• heightened awareness of heartbeat (palpitations), sudden loss of consciousness (syncope)
• high blood pressure (hypertension), low blood pressure (hypotension)
• difficulty breathing (dyspnoea)
• stomach ache, abdominal pain
• difficulty in digestion (dyspepsia), diarrhoea
• skin rash
• back pain
• feeling of fatigue, chest pain

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

• nausea

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

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 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 special storage conditions.
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.
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 Dromos contains
Dromos 500 mg tablets

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

Description of the appearance of Dromos and package contents
Dromos 500 mg tablets
Each package contains 30 tablets of 500 mg in blisters
Marketing Authorization Holder
Alfasigma S.p.A. – Viale Sarca, n. 223 – Milano (MI)
Manufacturer
Alfasigma S.p.A. Via Pontina Km 30,400 00071 Pomezia (RM)