HEPARIN-RATIOPHARM

HEPARIN-RATIOPHARM Sport Gel

Important notes (mandatory information)

Heparin-ratiopharm Sport Gel. Areas of application: for supportive treatment of acute swelling conditions after blunt injuries (bruises, haematomas) and superficial phlebitis, provided that these cannot be treated by compression. Warning: Contains macrogolglycerol ricinoleate!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin-ratiopharm Sport Gel
Active ingredient: Heparin sodium 60,000 IU/100 g gel

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 10 days, contact your doctor.

What this package leaflet contains

1. WHAT IS HEPARIN-RATIOPHARM SPORT GEL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING HEPARIN-RATIOPHARM SPORT GEL?
3. HOW IS HEPARIN-RATIOPHARM SPORT GEL USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD HEPARIN-RATIOPHARM SPORT GEL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS HEPARIN-RATIOPHARM SPORT GEL AND WHAT IS IT USED FOR?

Heparin-ratiopharm Sport Gel is a medicine for reducing swelling. Heparin-ratiopharm Sport Gel is used for supportive treatment of acute swelling conditions after blunt injuries (bruises, haematomas) and superficial phlebitis, provided that these cannot be treated by compression.

2. WHAT SHOULD YOU CONSIDER BEFORE USING HEPARIN-RATIOPHARM SPORT GEL?

Heparin-ratiopharm Sport Gel 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 historically known allergic drop in the number of platelets (thrombocytopenia type II) caused by heparin.

Warnings and precautions

Please talk to your doctor or pharmacist before using Heparin-ratiopharm Sport Gel. Due to its alcohol content, Heparin-ratiopharm Sport Gel should not be applied to mucous membranes, open or inflamed skin areas (e.g. sunburn) or come into contact with the eyes, as a burning sensation may occur. If new symptoms occur that may indicate 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.

Use of Heparin-ratiopharm Sport Gel together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Interactions with other medicines are not known when applied locally.

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.

Driving and using machines

No effects on the ability to drive and use machines are known.

Heparin-ratiopharm Sport Gel contains macrogolglycerol ricinoleate

Macrogolglycerol ricinoleate can cause skin irritation.

3. HOW IS HEPARIN-RATIOPHARM SPORT GEL USED?

Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Heparin-ratiopharm Sport Gel should be applied thinly and evenly to the affected area 2 to 3 times a day.

Duration of use

Unless otherwise prescribed, Heparin-ratiopharm Sport Gel should not be used for longer than 10 days.

If you have used more Heparin-ratiopharm Sport Gel than you should

No overdose symptoms are known when used as directed.

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 assess side effects

The following categories are used for the frequency information on 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.

Skin

Allergic reactions to heparin when applied to the skin are very rare. However, in individual cases, allergic reactions such as reddening of the skin and itching may occur, which usually disappear quickly after discontinuation of the preparation. Macrogolglycerol ricinoleate can cause skin irritation. Heparin-ratiopharm Sport Gel should be discontinued if allergic skin reactions occur. Please inform your doctor about this.

Blood and blood-forming system

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 platelet count to < 50% of the initial value, with arterial and venous thromboses or embolisms) has not been reported to date when applied to the skin. However, since the absorption of heparin through healthy skin has been described, this risk cannot be ruled out with certainty. Therefore, increased attention is indicated (see section 2. "Warnings and precautions"). It is known from the use of heparin, which is administered as an injection, 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. If you notice symptoms that could indicate thrombosis or pulmonary embolism, please inform your doctor immediately. Please also refer to section 2 "Warnings and precautions"

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package 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 SHOULD HEPARIN-RATIOPHARM SPORT GEL BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and tube after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Shelf life after opening the tube: This medicine can be stored for 6 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Heparin-ratiopharm Sport Gel contains

The active ingredient is: Heparin sodium. 100 g gel contains 60,000 IU heparin sodium (from pig intestinal mucosa). The other ingredients are: Carbomer 980, macrogolglycerol ricinoleate 36 (Ph. Eur.), propan-2-ol (Ph. Eur.), rosemary oil, mountain pine oil, purified water, trometamol.

What Heparin-ratiopharm Sport Gel looks like and contents of the pack

Colourless to slightly yellowish, transparent to slightly cloudy gel. Heparin-ratiopharm Sport Gel is available in packs of 50, 100 and 150 g gel.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in December 2015.

Source: Information from the package leaflet
Status: 09/2017
Areas of application: for supportive treatment of acute swelling conditions after blunt injuries (bruises, haematomas) and superficial phlebitis, provided that these cannot be treated by compression. Warning: Contains macrogolglycerol ricinoleate!