MIDRO TEA

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986

This medicine is to be supplied by physician's prescription only

MIDRO Tea

Tea 75%

Active ingredients:

Each 100 g contains: Sennae Folium 75 g

75% Folium Sennae equivalent to 2.7% hydroxyanthracenes

Inactive ingredients and allergens: see section 6 "Additional information".

Read the entire leaflet carefully before you start using this medicine. This leaflet contains essential information about this medicine. If you

have any further questions, refer to the physician or the pharmacist.

This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them, even if it seems to you that their medical

condition is similar.

The medicine is not intended for children under the age of 12 years.

1.

What is this medicine intended for?

This medicine is indicated for the treatment of constipation.

Therapeutic group: Laxative.

2.

Before using this medicine

. X . Do not use this medicine if:

You are sensitive to any of the ingredients that this medicine contains

In the case of intestinal occlusion

In the case of chronic intestinal dysfunction

In the case of acute intestinal inflammation such as Crohn's disease or ulcerative colitis

In the case of intestinal bleeding

In the case of gastrointestinal tract obstruction

In the case of symptoms of appendicitis

In the case of abdominal pain of unknown reason

In the case of severe dehydration associated with loss of fluids and electrolytes

Children under 12 years

.! Special warnings regarding the use of this medicine

Prolonged use may cause diarrhea and dependence on laxative preparations of this type.

Do not use this medicine frequently, or for a long period exceeding 1-2 weeks, without consulting a physician.

If you are sensitive to any type of food or medicine, inform your physician before commencing treatment with this medicine.

This preparation is indicated only for constipation continuing for several days. A lack of bowel movement for 1-2 days does not justify

use of this medicine.

Upon chronic use, abuse or use at dosages higher than the recommended dosages, you may develop diarrhea with fluid loss and

electrolyte imbalance (including potassium loss); dependence associated with the need to increase the dosage, paralytic ileus with

functional intestinal obstruction.

Do not use this preparation for other purposes, such as “body cleansing” etc.

Before using "Midro Tea", tell your physician if:

You are pregnant or breast-feeding.

You suffer or have previously suffered from impaired cardiac function.

You have rectal bleeding.

You have intense abdominal pain.

You have signs of appendicitis (such as: abdominal pain, nausea and vomiting).

If you are taking or have recently taken other medicines, including nonprescription medicines and nutritional supplements, inform your

physician or pharmacist. In particular if you are taking:

Other laxatives

Antacids

Diuretics

Licorice based medicines

Corticosteroids

Medicines for the treatment of heart failure (such as Digoxin)

Antiarrhythmic medicines

Antihistamines (such as Terfenadine)

Allow a lapse of at least two hours between taking this medicine and taking another oral medicine.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding you should consult a physician or pharmacist before using this medicine.

Driving and using machines

Midro Tea is not expected to affect the ability to drive or to operate machines. However, if you experience dizziness, you must be careful while

driving and operating machines

3.

How should you use the medicine?

You should check with the physician or the pharmacist if you are unsure.

This medicine is not intended for children under the age of 12 years.

The dosage and treatment will be determined only by the physician. The usual acceptable dosage is:

Unless instructed otherwise by the physician, chew 1/4 up to 1½ full measuring scoops (maximum 1.5 gram). Chew or swallow the medicine with

some water about 1 hour before bedtime.

Start with 1/2 full measuring scoop of Midro Tea.

Adjust the dose according to your needs by increasing or reducing it as required. Do not exceed the daily dose of 1½ full measuring scoops.

If there is no improvement in your condition within 1 week, refer to your physician.

Do not exceed the recommended dose.

Persist with the treatment as recommended by the physician.

Allow a lapse of at least two hours between taking this medicine and taking other oral medicines.

If you have accidentally taken a higher dose, or if a child has accidentally swallowed the medicine, go immediately to a hospital emergency

room and bring the medicine package with you.

How can you contribute to the success of the treatment?

Make sure your liquid intake is sufficient in order to help soften the stool. This preparation causes a bowel movement usually within 6-12 hours, but

occasionally more time is needed (up to 24 hours).

Do not take medicines in the dark! Check the label and the dose each time you take your medicine. Wear glasses if you need them.

If you have any further questions regarding the use of this medicine, consult the physician or the pharmacist.

4.

Side effects

Like all medicines, Midro Tea may cause side effects in some users. Do not be alarmed by reading the list of side effects. You may not

experience any of them.

Rash

Abdominal spasms

Diarrhea

Rare side effects (<1/10,000)

Unusual weakness or fatigue

Increased heart rate

Confusion

Abdominal flatulence

Abdominal pain

These effects may be signs of electrolyte loss. Upon occurrence of any of these side effects, stop the treatment and contact your physician

immediately.

This medicine may cause a change in the colour of the urine. Such a change should not be a cause for worry.

If any side effect gets worse, or if you suffer from a side effect not mentioned in the leaflet, or if there is a change in your general health, you

should consult the physician immediately.

Reporting side effects:

Side effects can be reported to the Ministry of Health (MoH) by clicking on the "Report on side effects due to medication therapy" link on the MoH

home page (www.health.gov.il) which refers to the online form for side effects reporting, or by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il

5.

How to store the medicine?

Avoid poisoning! This medicine and all other medicine should be kept in a close place out of the reach of children and/or infants in order

to avoid poisoning. Do not induce vomiting unless explicitly instructed to do so by a physician.

Do not use the medicine after the expiry date (exp. date) appearing on the package. The expiry date refers to the last day of that month.

Do not store at a temperature above 25°C.

Avoid exposure to light.

After first opening, use the medicine for up to 1 year of the day of opening, but never use it after the expiration date indicated on the

package.

Store in the original package.

6.

Additional information

In addition to the active ingredient the medicine also contains:

Fructus Carvi, Radix Liquiritiae, Folium Menthae Piperitae, Malvae Flower, Calcatrippae Flower.

What does the medicine look like and what are the contents of the package:

Midro Tea product is a herbal mixture of heterogeneous green color with purple flakes, of mild aromatic odor. The mixture is packed in

a paper bag stored in a carton box.

The product package contains 80 grams.

Registration holder: Neopharm (ISRAEL) 1996 Ltd., POB 7063, Petach-Tikva 49170.

Manufacturer: Midro AG, Switzerland.

Registration number of the medicine in the National Drug Registry of the Ministry of Health: 130-27-20919-00.

This leaflet was checked and approved by the Ministry of Health in: 03/2016.

Midro

®

Tea

________________________________________________________________________________________________________________

MIDRO

_______________________________________________________________________________________________________________

Name of the medicinal product

Midro Tea

Composition

Active substance: Sennae folium (senna leaf).

Excipients: caraway fruit, peppermint leaf, liquorice root, common mallow flowers, larkspur flowers.

Pharmaceutical form and amount of active substance per unit

1 g tea contains 750 mg senna leaves, corresponding to 19–21 mg hydroxyanthracene derivatives calculated as sennoside B.

Therapeutic

Indications

Laxative

Posology/Method of administration

Adults and children aged 12 years and older: take 0.5 to 1.5 g (e.g. ¼ to 1½ measuring spoonfuls or ½ to 1 sachet) in the evening,

preferably 1 hour before bedtime, by chewing and/or swallowing with some water.

The daily dose may vary from one individual to another. Treatment should normally start with a small dose (e.g. ¼ measuring spoonful or ½

sachet), which should be increased according to need. The maximum daily dose must not exceed 30 mg hydroxyanthracene derivatives,

which corresponds to 1½ measuring spoonfuls or 1 sachet. The correct individual dose is the smallest dose needed to obtain soft and well-

formed stools.

The product may be taken only occasionally and for no longer than 1 to 2 weeks.

Contraindications

Diseases of the gastrointestinal tract (acute bowel inflammation, such as Crohn’s disease and ulcerative colitis, strictures of the

gastrointestinal system, intestinal obstruction or suspected appendicitis, abdominal pain of unknown origin); severe dehydration with fluid

and electrolyte losses; hypersensitivity to the active substance or to any of the excipients according to the composition.

Children under 12 years.

Warnings and precautions

The long-term use of laxatives must be avoided. Abuse with subsequent loss of fluid and electrolytes can have undesirable consequences

such as: dependence, possibly accompanied by the need to increase the dose, fluid and electrolyte imbalance (mainly hypokalaemia), as

well as colonic atony with functional restriction

In the event of permanent use, medical surveillance is required.

Interactions

As hypokalaemia is possible, interactions can be expected with digitalis glycosides, type I antiarrhythmic agents and certain antihistamines

such as terfenadine.

Concomitant use of other medications that may cause hypokalaemia (such as diuretics, corticosteroids, liquorice) will aggravate

hypokalaemia.

Pregnancy/Lactation

No harmful effects on the foetus have been reported to date when the recommended dosages were observed during pregnancy.

Nevertheless, based on experimental data on the genotoxicity of various anthranoids, ingestion of Midro Tea during pregnancy is not

recommended. Midro Tea is not recommended for use during breastfeeding, as there are insufficient data on the passage of metabolites into

human milk.

Effects on ability to drive and use machines

The effect of this medicinal product on the ability to drive and use machines has not been studied; however, this is unlikely.

Undesirable effects

In a few cases: bloating, cramp-like gastrointestinal disturbances or diarrhoea. A dose reduction is required in such cases. Yellow or brown

discolouration of the urine (depending on pH) due to metabolites. Such discolouration is not clinically relevant.

Diarrhoea may occur at high doses or with prolonged or frequent use, with fluid and electrolyte losses (particularly loss of potassium),

albuminuria and haematuria, as well as pigmentation of the intestinal mucosa (pseudomelanosis coli). However, the latter is mild and usually

resolves upon discontinuation of the product.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the

benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.health.gov.il ).

Overdose

Severe diarrhoea can occur in cases of acute overdose, with intestinal irritation and spasms, as well as significant electrolyte loss.

Therapeutic measures consist of administering absorbents and restoring the fluid and electrolyte balance. In the presence of gastric colic,

administer antispasmodic agents if necessary.

Properties/Effects

ATC code: A06AB56

Senna belongs to the group of stimulating laxatives of the anthracene type. The active products extracted from senna leaves – sennosides –

are anthraquinone glycosides, which become effective only after enzymatic transformation in the colon. The effect is based on active

secretion of electrolytes and water in the intestinal lumen. At the same time, absorption of electrolytes and water through the colon is

restricted. The result is a softening of the intestinal contents and an increase in their volume, which increases the filling pressure in the

intestine and ultimately stimulates and accelerates peristaltic movement. Defecation takes place 8–12 hours later.

Pharmacokinetics

Glycosides with a beta-glycosidic bond (sennosides) are active prodrugs, which are neither cleaved nor absorbed in the upper

gastrointestinal tract. They are degraded to rhein anthrone in the colon by the action of bacterial enzymes. Rhein anthrone is the metabolite

with a laxative effect. The systemic availability of rhein anthrone is very low. Animal experiments using radioactive rhein anthrone directly

applied to the caecum have shown that absorption is <10%. Oxygen oxidises rhein anthrone to rhein and sennidins, which are recovered in

the blood as glucuronides and sulphates.

Preclinical data

After oral administration of sennosides in rats and guinea pigs, no embryotoxic or foetotoxic reaction has been observed. Furthermore, there

was no influence on the postnatal development of neonates, maternal behaviour or the fertility of male and female rats. No data are

available on the herbal preparation.

A senna extract, as well as aloe emodin, were shown to be mutagenic in vitro. Conversely, sennosides

A and B, as well as rhein, yielded

negative results. In vivo mutagenicity studies on a senna fruit extract proved negative.

The active metabolites, such as rhein, pass into human milk in small quantities. No laxative effect has been observed in breast-fed infants. In

animal experiments, passage through the placental barrier is extremely low for rhein.

Special comments

Keep Midro Tea out of the reach of children.

This medicinal product must not be used after the date stated on the container after “EXP”.

Notes on storage

Do not store above 25°C. Protect from light.

Presentation

Midro Tea 80 g. (B)

Registration holder

Neopharm (Israel)1996 Ltd.,

P.O.Box 7063, Petach Tiqva 49170

Marketing authorisation number

130-27-20919-00

The format of this leaflet has been defined by the MOH and its content has been checked and approved on 12.04.2016