Altan

Italy
Brand name Altan
Form tablets
Active substance / Dosage
PROMELASE
Prescription type Prescription only
ATC code
B06AA
Registration number 026419
Manufacturer FARMAKA S.R.L.

Table of Contents

Package leaflet: Information for the patient

ALTAN 30 mg film-coated tablets

Promelase
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 they have the same symptoms as you, because 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 ALTAN is and what it is used for
  2. What you need to know before taking ALTAN
  3. How to take ALTAN
  4. Possible side effects
  5. How to store ALTAN
  6. Contents of the pack and other information

1. What ALTAN is and what it is used for

ALTAN contains the active substance bromelain, a substance derived from a plant, which acts
by reducing inflammation and making mucus in the respiratory tract less viscous.
ALTAN, used in combination with appropriate therapy using other medicines, is indicated for:

  • acute and chronic respiratory tract diseases;
  • inflammation and swelling due to accumulation of blood (tumefaction) or fluids (edema), caused by:
    • fractures, edema and hematomas following trauma or surgical procedures;
    • dental problems (periapical conditions, gingival alveolar abscesses, tooth extraction, impacted teeth or difficulty in tooth eruption);
    • acute and chronic inflammation of the nose and ear;
    • inflammation of the veins (thrombophlebitis);
    • breast engorgement during lactation (mammary congestion), surgical incision made during childbirth (episiotomy);
    • urinary tract infections (cystitis).

2. What you need to know before taking ALTAN

Do not take ALTAN

  • if you are allergic to promelase or to any of the other ingredients of this medicine (listed in section 6);
  • if you have a hereditary disease characterized by severe blood disorders (haemophilia);
  • if you have an increased tendency to bleeding (haemorrhagic diathesis);
  • if you suffer from severe liver (hepatopathies) or kidney (nephropathies) diseases;
  • if you have stomach lesions (peptic ulcer).

Warnings and precautions
Talk to your doctor or pharmacist before taking ALTAN.
Other medicines and ALTAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between ALTAN and other medicines are known.
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.
Take this medicine during pregnancy and breastfeeding only if clearly needed and under the direct supervision of your doctor.
Driving and using machines
The use of ALTAN does not impair the ability to drive vehicles or operate machinery.
ALTAN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take ALTAN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 1–3 tablets (30–90 mg) daily, taken in two or more divided doses throughout the day (within 24 hours).
If you take more ALTAN than you should
Cases of overdose have not been reported.
In the event of accidental ingestion or intake of an excessive dose of ALTAN, contact your doctor immediately or go to the nearest hospital.
If you forget to take ALTAN
Do not take a double dose to make up for the missed tablet.
If you stop treatment with Altan
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.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

  • decreased appetite (anorexia);
  • stomach pain (gastralgia), stomach burning (gastric pyrosis), nausea, vomiting, diarrhoea;
  • allergic skin reaction.

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 through 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 ALTAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month and to the product in
intact packaging, properly stored.
Store at a temperature not exceeding 25 °C.
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 ALTAN contains

  • The active substance is promelase. Each tablet contains 30 mg of promelase.
  • The other ingredients are: maltose, carboxymethylcellulose calcium, magnesium stearate, methacrylic acid copolymer, triethyl citrate, talc, sodium hydroxide.

Description of the appearance of ALTAN and package contents
30 mg film-coated tablets: carton containing 20 tablets.
Marketing Authorization Holder
Farmaka S.r.l.
Via Villapizzone, 26
20156 Milan (MI), Italy
Manufacturer
Farmaceutici Formenti SpA
Via Giuseppe di Vittorio, 2
21040 Origgio (VA), Italy