Diohespan

Package Leaflet: Information for the Patient

Diohespan, 1000 mg, Tablets

Diosmin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Diohespan and what is it used for
• 2. Important information before taking Diohespan
• 3. How to take Diohespan
• 4. Possible side effects
• 5. How to store Diohespan
• 6. Contents of the pack and other information

1. What is Diohespan and what is it used for

Diohespan increases venous tone and has a protective effect on blood vessels. It also increases lymphatic drainage by enhancing the peristalsis (motility) of lymphatic vessels and lymph flow. The medicine acts on microcirculation, reducing the permeability of small blood vessels, perivascular inflammation, and stasis in microcirculation. It also reduces the susceptibility to rupture of small blood vessels.

Indications for Use

• Treatment of symptoms of chronic venous insufficiency of the lower limbs, such as: feeling of heaviness in the legs, leg pain, nocturnal cramps, swelling.
• Treatment of ulcers in the course of venous insufficiency of the lower limbs as a supplement to other therapeutic methods.
• Symptomatic treatment in case of exacerbation of symptoms associated with anal hemorrhoids (hemorrhoids).

2. Important Information Before Taking Diohespan

When Not to Take Diohespan:

• if you are allergic to diosmin or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Before starting to take Diohespan, consult your doctor.
If symptoms associated with anal hemorrhoids persist or worsen despite the use of the medicine, consult your doctor.
Treatment of symptoms associated with anal hemorrhoids should be short-term.

Diohespan and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions with other medicines have been reported.

Taking Diohespan with Food and Drink

Take the medicine during meals.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only if necessary, and only on the advice of a doctor. If you become pregnant during treatment, consult your doctor, as only your doctor can decide whether to continue treatment.
Breastfeeding
Due to the lack of data on the penetration of Diohespan into breast milk, the use of the medicine during breastfeeding is not recommended.

Driving and Using Machines

The medicine has no effect on driving or operating machinery.

3. How to Take Diohespan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is for oral use.

Recommended Dose

Chronic venous insufficiency of the lower limbs:
1 tablet once a day, during a meal.
Ulcers in the course of venous insufficiency of the lower limbs:
1 tablet once a day, during a meal.
Exacerbation of symptoms related to anal hemorrhoids:
3 tablets a day for 4 days, then 2 tablets a day for the next 3 days.
The dividing line on the tablet only facilitates its crushing to make it easier to swallow, and not to divide it into equal doses.
Do not take more than the recommended dose of the medicine.

Taking More Than the Recommended Dose of Diohespan

If you have taken more than the recommended dose of the medicine, contact your doctor.
No cases of poisoning with the medicine due to overdose have been reported.
Taking more than the recommended dose of the medicine may cause gastrointestinal disorders, vomiting, and nausea.

Missing a Dose of Diohespan

Continue taking the medicine, without increasing the next dose.
Do not take a double dose to make up for a missed dose.

Stopping Treatment with Diohespan

There is no data on the effects of stopping treatment.
If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

Following Side Effects May Occur

Rarely(occurring in 1 to 10 people out of 10,000):

• diarrhea, indigestion, nausea, vomiting;
• dizziness, headache, malaise;
• itching, rash (itchy, red bumps on the skin), urticaria (light red, itchy blisters on the skin).

The occurrence of any of the above side effects does not necessitate the withdrawal of the medicine.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Diohespan

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of the month.
Markings on the blister:
Lot – batch number;
EXP – expiry date.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Diohespan Contains

• The active substance is diosmin.

One tablet contains 1000 mg of micronized diosmin.

• The other ingredients are: polyvinyl alcohol, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate.

What Diohespan Looks Like and Contents of the Pack

The medicine is in the form of tablets with a dividing line. The dividing line on the tablet only facilitates its crushing to make it easier to swallow, and not to divide it into equal doses.
The tablets are packaged in blisters of 10 tablets and a cardboard box.
The pack contains: 30 tablets, 60 tablets, 90 tablets, or 120 tablets.

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
Date of Last Revision of the Leaflet:22.06.2020