D-Forzhekt

Do not take D-Forzhekt:

• if you are hypersensitive to any of its components;
• if you have serious malfunctions of the overall health, such as dehydration, or a severe heart failure;
• if you suffer from advanced carcinoma, or any other bowel disease with a significant mucosal damage;
• if you are prone to a developing or existing intestinal, or gastrointestinal obstruction;
• if you have a perforation or risk of developing a perforation of the gastrointestinal tract;
• if you suffer from disorders of gastric emptying (e.g. paresis of the stomach);
• if you have toxic colitis or toxic megacolon;
• if you are under 18 years old.

Warnings and precautions

Elderly people with various concomitant diseases are recommended to use the medicinal product under medical supervision.

Nausea, vomiting, or bloating may occur at the beginning of taking the medicinal product. These symptoms normally disappear with further use.

If you experience sudden abdominal pain or rectal bleeding while you are taking D-Forzhekt before bowel examination, you should immediately contact your doctor or seek medical attention.

D-Forzhekt contains polyethylene glycol. Very rarely, an allergic reaction (rash, hives, or swelling) caused by polyethylene glycol can be observed. Extremely rare cases of anaphylactic shocks have been reported. This medicinal product is not recommended for patients with hypersensitivity to polyethylene glycol.

Electrolyte disturbances are not expected when taking the medicinal product due to its isotonic composition. Still such a risk exists. The medicinal product should be used with caution in patients with a tendency to develop water and electrolyte disorders (for example, in patients with impaired renal function, with heart failure, or with concomitant use of diuretics).

The medicinal product should be used with caution and under medical supervision in patients with a tendency to aspiration (in bedridden patients with neurological or motor disorders) due to the risk of developing aspiration pneumonia. In such cases, patients take the medicinal product in a seated position or with the help of a nasal probe. Patients with heart and kidney failure are at risk of developing acute pulmonary edema due to fluid overload.

One sachet of D-Forzhekt contains 1.967 g of sodium. This should be taken into account when handing patients with tight dietary salt restrictions.

Ischemic colitis

During the post-approval stage a series of ischemic colitis cases was reported. It included severe cases after taking macrogol-containing medicinal products to prepare the intestines for examination. Macrogol should be used with caution in patients with known risk factors for ischemic colitis, or when co-administered with stimulant laxatives (such as bisacodyl or picosulfate sodium). Patients with sudden abdominal pains, rectal bleeding, or other symptoms of ischemic colitis should be examined immediately.

Before taking this medicinal product you should consult your doctor if you have at least one of the diseases or health conditions listed above.

Other medicinal products and D-Forzhekt

Before prescribing a medicinal product, a doctor should be informed about any medications taken orally by a patient. Diarrhea caused by the use of D-Forzhekt may lead to impaired absorption of other medicinal products taken by mouth in conjunction with D-Forzhekt. Therefore, it is recommended to take D-Forzhekt at least 2 hours after taking other medicinal products. You should not take any other medicines before and after the use of a laxative until the examination is completed. Especially, it may decrease the effectiveness of medicinal products with a narrow therapeutic range and a short elimination half-life.

D-Forzhekt with food, drink, and alcohol

Patients should not eat solid food 2-3 hours before taking the medicinal product and until the end of the examination. The amount of liquid is not limited.

Drinking alcohol is not recommended because it can unpredictably interfere with arterial blood pressure control and kidney function control.

Pregnancy, breastfeeding, and fertility

If you are pregnant, expecting pregnancy, going to have a baby, or breastfeeding, ask your doctor for advice before taking this medicine.

D-Forzhekt can be used in pregnant women only in cases where the benefit outweighs the risk of using the medicinal product.

There are no data on excretion of macrogol 4000 into breast milk. D-Forzhekt can be used during breastfeeding.

The medicinal product does not affect reproductivity due to insignificant absorption of macrogol 4000.

Effects on ability to drive and use machines

Nobody has studied the effect of the medicinal product on driving a car and using machines.

Dosage

Always take the medicinal product in full accordance with the recommendations of your doctor. Check with your doctor if you are not sure.

D-Forzhekt can only be used in adult patients. The medicinal product should be taken orally.

The solution is prepared immediately before use. D-Forzhekt should be made up by dissolving the contents of one sachet in 1 liter of water. Gradually pour in the powder and stir well until all the powder is dissolved. The required dose of the medicinal product is taken in parts: 1 glass of the solution during 15 minutes in separate sips, 1 liter during 1 hour. The dose of the medicinal product is set at the rate of 1 liter of the solution per 15-20 kg of body weight. That approximately corresponds to 3-4 liters of the solution per person.

The use of the medicinal product can be carried out in two ways:

One-stage preparation: the solution is taken once (4 liters in the evening, on the eve of the examination or operation).

Two-stage preparation: 2-3 liters of solution are taken the night before, and the remainder of the dose is taken in the morning. The intake of the medicinal product should be completed 3-4 hours before the procedure.

The medication regimen for the medicinal product is recommended by the attending doctor in accordance with the clinical condition of the patient and the potential risk of complications.

Patients should not eat solid food 2-3 hours before taking the medicinal product and until the end of the examination.

Patients with renal insufficiency

Data on the use of the medicinal product in this group of patients are limited (see Section Warnings and precautions).

Use in children and adolescents

The safety and efficacy of using the medicinal product in children under 18 years old have not been studied. Therefore, D-Forzhekt is not recommended for children and adolescents.

If you take more D-Forzhekt than recommended

Overdose cases have not been reported.

However, in cases of severe diarrhea due to an overdose, it is necessary to monitor the state of the water and electrolyte balance, and hydration level. For this purpose you should contact the nearest emergency room or immediately inform your doctor for further health monitoring.

Like all medicines, D-Forzhekt can cause side effects, although not everyone gets them.

Nausea, vomiting, or bloating may occur at the beginning of taking the medicinal product. These symptoms normally disappear with further use.

Immune System Disorders

There are separate reports of the development of hypersensitivity reactions such as:

• anaphylactic shock (acute hypersensitivity reaction, accompanied by a decrease in systolic blood pressure below 90 mm Hg, leading to circulatory failure and hypoxia in all vital organs);
• angioedema (rapid swelling of tissues, such as the eyelids, face, lips, mouth, tongue or throat, which may cause difficulty in breathing);
• hives;
• rash;
• itching.

Gastrointestinal disorders

Nausea, abdominal pain, bloating, and vomiting have been frequently reported.

If you get any side effects, talk to your doctor. This recommendation applies to any possible side effects, including those not listed in the leaflet. You can report to the information database on adverse reactions (side effects), or on inefficiency of medicinal products (Center for Examinations and Tests in Health Service: http://www.rceth.by) or to the manufacturer ACADEMPHARM via an electronic application form on their website: http://academpharm.by/en.

By reporting side effects you can help provide more information on the safety of this medicinal product.

Keep this medicinal product out of the sight and reach of children.

The storage life is 2 years. Do not use this medicinal product after the expiry date which is specified on the carton and sachets. The expiry date refers to the first day of the specified month.

Do not use this medicinal product if you notice that any of the sachets is damaged.

You should store unopened sachets below 25ºC.

Each sachet of D-Forzhekt contains:
Active ingredients: macrogol 4000 (64.00 g), anhydrous sodium sulfate (5.70 g), sodium bicarbonate (1.68 g), sodium chloride (1.46 g), and potassium chloride (0.75 g);
Excipients: sodium saccharin.

Presentation and packaging
Powder for oral solution.

73.69 g of the medicinal product are sealed in a sachet made of a combined material based on aluminum foil. 4 sachets with a leaflet are packed in an outer carton.

Marketing authorization holder and manufacturer

State enterprise ACADEMPHARM
220141, 5/3 Kuprevicha Street, Minsk, Belarus,
Phone / Fax +375 17 268-63-64
production@academpharm.by
To report adverse reactions use the electronic application form on the manufacturer’s website: https://academpharm.by/en