HEPARIN-RATIOPHARM

HEPARIN-RATIOPHARM 180,000 IU Gel

Important notes (mandatory information)

Heparin-ratiopharm 180,000 Gel. Active ingredient: Heparin sodium. Areas of application: for supportive treatment of superficial phlebitis, provided that this cannot be treated by external pressure (compression). Warning: Contains propylene glycol and macrogolglycerol hydroxystearate.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin-ratiopharm 180,000 Gel
Active ingredient: Heparin sodium 180,000 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 want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice 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, talk to your doctor.

What this package leaflet contains

1. WHAT IS HEPARIN-RATIOPHARM 180,000 GEL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING HEPARIN-RATIOPHARM 180,000 GEL?
3. HOW IS HEPARIN-RATIOPHARM 180,000 GEL USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD HEPARIN-RATIOPHARM 180,000 GEL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS HEPARIN-RATIOPHARM 180,000 GEL AND WHAT IS IT USED FOR?

Heparin-ratiopharm 180,000 Gel is a medicine that inhibits blood clotting. Heparin-ratiopharm 180,000 Gel is used for supportive treatment of superficial phlebitis, provided that this cannot be treated by external pressure (compression). The primary treatment for superficial phlebitis of the lower extremities is compression therapy.

2. WHAT SHOULD YOU CONSIDER BEFORE USING HEPARIN-RATIOPHARM 180,000 GEL?

Heparin-ratiopharm 180,000 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 (type II thrombocytopenia) caused by heparin.

Warnings and precautions

Please talk to your doctor or pharmacist before using Heparin-ratiopharm 180,000 Gel. Heparin-ratiopharm 180,000 Gel should not be applied to mucous membranes, open or inflamed skin areas (e.g. sunburn) or come into contact with the eyes due to its alcohol content, as a burning sensation may occur. Absorption of heparin through healthy skin has been described for topically applied heparin. Therefore, 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 discoloration,
• 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 type II heparin-induced thrombocytopenia caused by heparin must be ruled out. Your doctor should therefore check your platelet count immediately.

Use of Heparin-ratiopharm 180,000 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 for topical (local) use of heparin-containing medicines on 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. To date, experience with the local (topical) use of heparin on 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. At very high doses of more than 180,000 IU heparin/100 g, increased bleeding tendency may occur. During childbirth, a certain form of anesthesia (epidural anesthesia) is prohibited if pregnant women are treated with heparin or other medicines that inhibit blood clotting.

Driving and using machines

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

Heparin-ratiopharm 180,000 Gel contains propylene glycol and macrogolglycerol hydroxystearate

Propylene glycol can cause skin irritation. Macrogolglycerol hydroxystearate can cause skin irritation.

3. HOW IS HEPARIN-RATIOPHARM 180,000 GEL 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. Unless otherwise prescribed by your doctor, the recommended dose is: Apply Heparin-ratiopharm 180,000 Gel evenly to the affected area 2 to 3 times a day. Apply the gel thinly to the part of the body to be treated and spread it evenly. Note: Do not massage Heparin-ratiopharm 180,000 Gel into varicose veins.

Method of administration

Apply to the skin.

Duration of use

The use of Heparin-ratiopharm 180,000 Gel should be continued until the symptoms have subsided. As a rule, a period of 1 - 2 weeks is sufficient for superficial phlebitis. If the symptoms have not improved after 14 days of regular use of Heparin-ratiopharm 180,000 Gel or if symptoms recur after the end of treatment, please consult your doctor.

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.

Skin

Allergic reactions to heparin have been observed very rarely to date. In individual cases, hypersensitivity reactions such as reddening of the skin and itching may occur when using Heparin-ratiopharm 180,000 Gel, which usually subside quickly after discontinuation of the preparation. In one individual case, a patchy, papular rash with bleeding developed after local application of a heparin gel in a patient with polycythemia vera (a disease associated with increased blood cell production) as an underlying condition.

Blood and blood-forming system

When using Heparin-ratiopharm 180,000 Gel, an existing bleeding tendency may increase; existing bruises (hematomas) may become more severe. Not known: A drop in the number of platelets (type II heparin-induced thrombocytopenia) caused by heparin (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, which can be fatal), 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 2. "What should you consider before using Heparin-ratiopharm 180,000 Gel?"). 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.

Countermeasures

If any of the possible side effects mentioned occur, discontinue treatment and consult your doctor.

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 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 180,000 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 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. Shelf life after first opening the tube: 1 year.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Heparin-ratiopharm 180,000 Gel contains

The active ingredient is: Heparin sodium. 100 g gel contain 180,000 IU heparin sodium (from pig intestinal mucosa). The other ingredients are: Carbomer 980, trometamol, macrogolglycerol hydroxystearate (Ph.Eur.), propylene glycol, propan-2-ol (Ph.Eur.), lavender oil, citronella oil, purified water.

What Heparin-ratiopharm 180,000 Gel looks like and contents of the pack

Clear to slightly cloudy, colorless to slightly yellowish gel. Heparin-ratiopharm 180,000 Gel is available in packs of 100 g 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: 02/2018
Active ingredient: Heparin sodium. Areas of application: for supportive treatment of superficial phlebitis, provided that this cannot be treated by external pressure (compression). Warning: Contains propylene glycol and macrogolglycerol hydroxystearate.