HEPARIN AL

HEPARIN AL Gel 50,000

Important notes (mandatory information)

Heparin AL Gel 50,000. Active ingredient: Heparin sodium. Areas of application: for supportive treatment of acute swelling after blunt injuries (bruises/haematomas).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin AL Gel 50,000
Active ingredient: Heparin sodium 50,000 IU per 100 g gel

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 10 days, you must see a doctor.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.

What this leaflet contains

1. WHAT IS HEPARIN AL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING HEPARIN AL?
3. HOW TO USE HEPARIN AL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE HEPARIN AL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS HEPARIN AL AND WHAT IS IT USED FOR?

Heparin AL is used for supportive treatment of acute swelling after blunt injuries (bruises/haematomas).

2. WHAT SHOULD YOU CONSIDER BEFORE USING HEPARIN AL?

Heparin AL must not be used:

• if you are allergic to heparin or any of the other ingredients of this medicine listed in section 6.
• if you have an acute or known history of an allergic drop in the number of platelets (thrombocytopenia type II) caused by heparin.

Warnings and precautions

Heparin AL should not be applied to open wounds, mucous membranes, inflamed skin areas (e.g. sunburn) and/or weeping eczema or come into contact with the eyes, as a burning sensation may occur. If new symptoms occur that may indicate a thrombosis or pulmonary embolism, such as:

• Swelling and warmth in the affected part of the body,
• reddened and tense skin, possibly bluish discolouration,
• tension and pain in the foot, calf and hollow of the knee (relief when elevated),
• sudden shortness of breath, chest pain and weakness/collapse

the presence of heparin-induced thrombocytopenia type II must be ruled out and the platelet count (thrombocyte count) must be checked immediately.

When using medicines that interfere with blood clotting at the same time, an increased risk of bleeding cannot be ruled out. Bruises may occur more frequently or increase in size (see section 2. "Using Heparin AL with other medicines"). During treatment with Heparin AL, injections into the muscle should be avoided due to the risk of bruising (haematomas).

Using Heparin AL with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. Interactions with other medicines are not known when applied locally, but cannot be ruled out, especially with prolonged use, as penetration of heparin through healthy skin has been described.

In particular, with medicines that interfere with blood clotting, such as:

• Platelet aggregation inhibitors (acetylsalicylic acid, ticlopidine, clopidogrel, dipyridamole in high doses)
• Fibrinolytics
• other anticoagulants (coumarin derivatives)
• non-steroidal anti-inflammatory drugs (phenylbutazone, indometacin, sulfinpyrazone)
• Glycoprotein II b/III a receptor antagonists
• Penicillin in high doses
• Dextrans

an increased risk of bleeding cannot be ruled out. Haematoma may occur more frequently.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Previous experience with use in pregnant and breast-feeding women has not provided any evidence of harmful effects. Heparin does not cross the placenta and does not pass into breast milk.

3. HOW TO USE HEPARIN AL?

Always use this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the recommended dose is: Heparin AL should be applied thinly and evenly to the affected area 2 to 3 times a day.

Duration of use

Heparin AL must not be used for longer than 10 days.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Blood and lymphatic system disorders

Not known: The occurrence of heparin-induced, antibody-mediated thrombocytopenia type II (HIT type II, reduction in the number of platelets < 100,000/µl or a rapid drop in the number of platelets to < 50% of the initial value), with arterial and venous thromboses or embolisms, which can be fatal, has not been reported to date with local application to the skin. However, since the absorption of heparin after local application through healthy skin has been described, this risk cannot be ruled out with certainty. Increased attention is therefore indicated (see section 2. "Warnings and precautions"). It is known from the use of parenteral heparin (heparin solutions for injection under the skin or into a vein) that in patients without pre-existing hypersensitivity to heparin, the drop in the number of platelets usually occurs 6 - 14 days after the start of treatment. In patients with hypersensitivity to heparin, this drop may occur within hours.

General disorders and administration site conditions

Allergic reactions to heparin when applied to the skin are very rare. However, in individual cases, allergic reactions such as redness of the skin and itching may occur, which disappear quickly after discontinuation of the preparation.

Countermeasures

Heparin AL should be discontinued if allergic skin reactions occur. Please inform your doctor about this. No further special measures are necessary.

Reporting of side effects

If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE HEPARIN AL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube after "Use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. After opening, Heparin AL Gel 50,000 has a shelf life of 6 months if stored properly. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Heparin AL contains

The active ingredient is heparin sodium. 100 g gel contains 0.25 g heparin sodium (mucosa from pigs), corresponding to 50,000 IU. The other ingredients are: Scots pine oil, levomenthol, pine needle oil, sodium edetate, 2,2',2"-nitrilotriethanol, polyacrylic acid, poly(oxyethylene)-6-glycerolmono/dialkanoate (C8 - C10), polysorbate 80, propan-2-ol, sorbitol, purified water.

What Heparin AL looks like and contents of the pack

Clear, colourless gel. Heparin AL is available in packs of 40 g gel and 100 g gel.

Pharmaceutical entrepreneur and manufacturer
Aliud Pharma GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This leaflet was last revised in July 2013.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Heparin sodium. Areas of application: for supportive treatment of acute swelling after blunt injuries (bruises/haematomas).