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PAROVEN CAPSULES 250MG

Active substance(s): OXERUTINS

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AWF 19852 – OTDC 334749
PAROVEN 250 MG 120 CAP GB_308368_PIL
148 x 210 mm – Recto/Verso
1199
Black
Univers LT Std
Text body: 7 pts

Kemwell Biopharma Pvt. Ltd.
PET002154-UK – KR/Drugs/KTK/25/460/2001

Pre-press

Ducommun sa – DO-14-E1256 – 02.05.2014

10 mm

10 mm

5

Recto

Paroven Capsules
®

Oxerutins 250 mg

88.5 mm

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Always take this medicine exactly as your doctor has told you or as described in this leaflet.
–– Keep this leaflet. You may need to read it again.
–– If you have any further questions, ask your doctor or pharmacist.
–– This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
–– If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Paroven Capsules are and what they are used for
2. Before you take Paroven Capsules
3. How to take Paroven Capsules
4. Possible side effects
5. How to store Paroven Capsules
6. Further information

1. WHAT PAROVEN CAPSULES ARE AND WHAT THEY ARE USED FOR

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It is recommended that such patients also wear elastic support (usually compression stockings) in CVI; in these
cases, Paroven Capsules have been shown to produce additional benefit.

2. BEFORE YOU TAKE PAROVEN CAPSULES
Do not take Paroven Capsules if you are:
• allergic to oxerutins or any of the other ingredients of Paroven Capsules listed in Section 6 and at the end of
Section 2.
Take special care with Paroven Capsules if you:
• have lower leg swelling caused by heart, liver or kidney disease
If these conditions apply to you, please tell your doctor or pharmacist before taking Paroven Capsules.
Children and adolescents
Paroven Capsules are not recommended in children.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those
obtained without a prescription.
Taking Paroven Capsules with food and drink
The capsules can be taken with a drink or at mealtimes. There are no special requirements.
Pregnancy, breast-feeding and fertility
Paroven Capsules should not be used during the first three months of pregnancy. Do not use if you are pregnant,
breast-feeding, think you might be pregnant or are planning to have a baby unless advised by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Paroven Capsules have no influence on the ability to drive and use machines. If you experience tiredness or dizziness after using this product, do not drive or use machinery.

3. HOW TO TAKE PAROVEN CAPSULES

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Always take Paroven Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.
Follow these instructions carefully.

148 mm

35 mm

Pharma code 1199

Paroven Capsules relieve ankle swelling (oedema) due to chronic venous insufficiency (CVI). In patients with varicose
veins and some other diseases of the leg veins, these small vessels have an excessive leakage which cause swelling of the ankles. Paroven Capsules also reduce this swelling and relieve the associated common symptoms such
as aching, tired, heavy, swollen, painful and restless legs, pins and needles and night cramps.

Pharma code 1199

Paroven Capsules contain oxerutins as the active ingredient, which belongs to a group of medicines which act on
small blood vessels (systemic vasoprotectors).
Paroven Capsules stabilise the vascular wall, which lead to a reduction in the permeability of the vessels and subsequently to a diminution of swelling (oedema).

Draft Z
Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 19852 – OTDC 334749
PAROVEN 250 MG 120 CAP GB_308368_PIL
148 x 210 mm – Recto/Verso
1199
Black
Univers LT Std
Text body: 7 pts

Kemwell Biopharma Pvt. Ltd.
PET002154-UK – KR/Drugs/KTK/25/460/2001

Pre-press

Ducommun sa – DO-14-E1256 – 02.05.2014

10 mm

10 mm

5

Verso
The usual dose is as follows:
Adults and the Elderly
• Take 2 capsules (500 mg) twice a day.
• Swallow the capsules whole; do not crush or chew the capsules.
• Capn be taken with or without food.
If no improvement in leg swelling is seen, please consult your doctor.
Children
Paroven Capsules are not recommended for children under 12 years of age.

If you forget to take Paroven Capsules
If you forget to take the capsules, take them as soon as possible unless it is time for the next dose. Do not take
double the dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

88.5 mm

If you take more Paroven Capsules than you should
If you accidentally take too many Paroven Capsules, or suspect that a child has taken the capsules, contact your
doctor or hospital casualty department immediately. Take the carton and capsules with you if possible.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Paroven can cause side effects, although not everybody gets them. The reactions are usually
mild.
Stop taking the Capsules and tell your doctor immediately if you notice the following very rare symptoms:
• skin rash, swelling of the face, lips, tongue or throat
• hives
• difficulty breathing or swallowing
as these may be the first signs of an allergic reaction which may become severe

If you get any other side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
Reporting of suspect adverse reactions is an important way to continuously monitor the benefit/risk balance of the
medicinal product in the real conditions of use. Healthcare professionals are asked to report any suspected adverse
reaction via the Yellow Card Scheme, www.mhra.gov.uk/yellowcard.

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5. HOW TO STORE PAROVEN CAPSULES
Keep out of the reach and sight of children.
Protect from moisture and store in a dry place in the original pack.
Do not use Paroven Capsules after the expiry ‘EXP’ date which is stated on the blister and the carton. The ‘EXP’ date
refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Paroven Capsules contain
The active ingredient is oxerutins 250 mg
The other ingredients are polyethylene glycol, gelatin, titanium dioxide E171, shellac, yellow iron oxide E172, black
iron oxide E172.
What Paroven Capsules look like and contents of the pack
Paroven Capsules are opaque, greyish-yellow in colour.
Paroven Capsules are available in blister packs of 120 capsules.
Marketing Authorisation Holder
Novartis Consumer Health
Camberley, Surrey
GU15 3YL, UK.

Manufacturer
Kemwell AB
Rapsgatan 7, SE-751 82
Uppsala, Sweden

For any information about this medicinal product, please contact the Marketing Authorisation Holder.
This leaflet was last approved in March 2014.

5

GB 308368 – PET002154-UK – KR/Drugs/KTK/25/460/2001

148 mm

35 mm

Pharma code 1199

Very rare (seen in less than 1 in 10,000 people and in more than 1 in 100,000 people):
• allergic reactions (see advice above)
• dizziness, headache, flushing, tiredness, nausea, vomiting, photosensitivity reactions (reaction of the skin to sunlight), alopecia (hairloss), arthralgia (joint pain). These are usually mild and disappear rapidly on stopping treatment.
If any of the side effects gets serious, or if you have any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Pharma code 1199

The side effects listed below have also been reported
Rare (seen in less than 1 in 1000 people and in more than 1 in 10,000 people):
• Skin rashes with itching/scaling
• Gastrointestinal disorders, including (wind), diarrhoea, abdominal pain, stomach discomfort, dyspepsia
(indigestion).

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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