HEPARIN-RATIOPHARM

HEPARIN-RATIOPHARM 60,000 Ointment

Important notes (mandatory information)

Heparin-ratiopharm 60,000 ointment. Areas of application: for supportive treatment in the case of acute swelling after blunt injuries (bruises, haematomas) and superficial phlebitis, provided that this cannot be treated by compression. Warning: Contains cetyl alcohol and potassium sorbate.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin-ratiopharm 60,000 ointment
Active ingredient: Heparin sodium 60,000 IU/100 g ointment

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 instructed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, consult 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, consult your doctor.

What this package leaflet contains

1. WHAT IS HEPARIN-RATIOPHARM 60,000 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING HEPARIN-RATIOPHARM 60,000?
3. HOW SHOULD HEPARIN-RATIOPHARM 60,000 BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD HEPARIN-RATIOPHARM 60,000 BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS HEPARIN-RATIOPHARM 60,000 AND WHAT IS IT USED FOR?

Heparin-ratiopharm 60,000 is an ointment for reducing swelling. Heparin-ratiopharm 60,000 is used for supportive treatment in the case of acute swelling after blunt injuries (bruises, haematomas) and superficial phlebitis, provided that this cannot be treated by compression.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING HEPARIN-RATIOPHARM 60,000?

Heparin-ratiopharm 60,000 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

Please talk to your doctor or pharmacist before using Heparin-ratiopharm 60,000. Heparin-ratiopharm 60,000 should not be applied to open wounds and/or weeping eczema. In the case of locally applied heparin, absorption of heparin through healthy skin has been described. Therefore, if new symptoms occur that may indicate a thrombosis or pulmonary embolism, such as:

• Swelling and a feeling of 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. Stop using Heparin-ratiopharm 60,000 and inform your doctor immediately.

Using Heparin-ratiopharm 60,000 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 in the case of local (topical) application of heparin-containing medicines to the skin.

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 the local (topical) application of heparin to the skin in pregnant and breast-feeding women has not provided any evidence of harmful effects. Heparin does not cross the placenta and can therefore not pass into the blood of the unborn child. Heparin also does not pass into breast milk. During birth, a certain form of anaesthesia (epidural anaesthesia) is prohibited if pregnant women are treated with heparin or other medicines that inhibit blood coagulation.

Driving and using machines

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

Heparin-ratiopharm 60,000 contains cetyl alcohol and potassium sorbate

Cetyl alcohol can cause localised skin irritation (e.g. contact dermatitis). Potassium sorbate can cause localised skin irritation (e.g. contact dermatitis).

3. HOW SHOULD HEPARIN-RATIOPHARM 60,000 BE USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Heparin-ratiopharm 60,000 should be applied to the affected area 2 to 3 times a day.

Method of administration

When used without a dressing

Apply the ointment thinly and evenly to the affected area 2 to 3 times a day.

When used under a dressing

Apply the ointment thickly and apply a dressing, possibly with an additional elastic bandage. If signs of intolerance appear when changing the dressing, the preparation should be discontinued and the compression treatment should be carried out without applying Heparin-ratiopharm 60,000.

Duration of use

Unless otherwise prescribed, Heparin-ratiopharm 60,000 should not be used for longer than 10 days.

If you have used more Heparin-ratiopharm 60,000 than you should

No overdose symptoms are known in the case of use as intended.

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.

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 (thrombocyte count) < 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 in the case of application to the skin. However, since the absorption of heparin 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 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 to 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 a thrombosis or pulmonary embolism, please inform your doctor immediately. Please also refer to section 2. "Warnings and precautions."

Skin and subcutaneous tissue disorders

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 the preparation has been discontinued. In the case of hypersensitivity to cetyl alcohol or potassium sorbate, allergic reactions on the skin (e.g. contact dermatitis), which may manifest as redness, hives and itching, may occur. In one individual case, a patchy, papular rash with haemorrhages developed after local application of a heparin gel in a patient with polycythaemia vera (a disease associated with increased blood cell production) as an underlying condition. Heparin-ratiopharm 60,000 should be discontinued if allergic skin reactions occur. Please inform your doctor about this.

Reporting of side effects

If you notice any side effects, consult 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 to provide more information on the safety of this medicine.

5. HOW SHOULD HEPARIN-RATIOPHARM 60,000 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 first opening the tube: 1 year.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Heparin-ratiopharm 60,000 contains

The active ingredient is: Heparin sodium. 100 g ointment contains 60,000 IU heparin sodium (from pig intestinal mucosa). The other ingredients are: Glycerol(mono/di/tri)-alkanoate(C12-C18), glycerol(mono/di)(palmitate/stearate)-sodium stearate (95:5), cetyl alcohol (Ph. Eur.), white petrolatum, perfume oil, dexpanthenol, potassium sorbate (Ph. Eur.), hydrochloric acid, purified water.

What Heparin-ratiopharm 60,000 looks like and contents of the pack

White to slightly yellowish, homogeneous, spreadable ointment Heparin-ratiopharm 60,000 is available in packs of 100 g and 150 g ointment.

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: 10/2017
Areas of application: for supportive treatment in the case of acute swelling after blunt injuries (bruises, haematomas) and superficial phlebitis, provided that this cannot be treated by compression. Warning: Contains cetyl alcohol and potassium sorbate.